Side Effects of pneumococcal conjugate vaccine: A Synthesis of Findings from 29 Studies

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This information is not medical advice and is not a substitute for diagnosis or treatment by a physician.Data sources and disclaimers (data limitations, copyright, etc.)The analysis on "Side Effects of pneumococcal conjugate vaccine: A Synthesis of Findings from 29 Studies" on this page is based on PubMed data provided by the U.S. National Library of Medicine (NLM). However, NLM does not endorse or verify these analyses.

This analysis is based on research papers included in PubMed, but medical research is constantly evolving and may not fully reflect the latest findings. There may also be biases towards certain research areas.

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Original Abstract of the Article

Major research findings

Pneumococcal conjugate vaccines have been a major advancement in the prevention of invasive pneumococcal disease in children. 29 A meta-analysis found that the 13-valent pneumococcal conjugate vaccine has a similar safety profile to the 7-valent vaccine and is as effective in preventing invasive pneumococcal disease caused by the seven common serotypes, with the potential to provide broader protection against six additional serotypes.

Vaccine responses in cord blood transplantation (CBT) survivors have been of great interest due to the lack of memory T and B cells in cord blood and recent declines in herd immunity to vaccine-preventable diseases. 13 This study analyzed vaccine responses in double-unit CBT recipients transplanted for hematologic malignancies. While GVHD (graft-versus-host disease) and prior rituximab administration can delay vaccination, CBT recipients, including adults and those with prior GVHD, exhibit similar vaccine response rates compared to adult donor allograft recipients, supporting the use of vaccines in CBT recipients.

Although generally safe, pneumococcal conjugate vaccines have been linked to rare but serious side effects. 8 reports a case of erythema multiforme (EM) in a 2.5-year-old boy following pneumococcal vaccination.

Reasons for side effects

Side effects from pneumococcal conjugate vaccines are believed to stem from the immune system's response to the vaccine. Introduction of antigens into the body triggers immune system activation, potentially leading to side effects such as inflammation and allergic reactions. However, the incidence of these side effects is very low, and most side effects are mild and transient.

Common side effects

Injection site reactions

Injection site reactions are the most common side effect of pneumococcal conjugate vaccines. 29 Most of these local reactions are mild or moderate in severity, typical of any injected vaccine.

Systemic reactions

Systemic reactions like fever, headache, and muscle aches can occur after pneumococcal conjugate vaccination. 29 Most of these systemic events are mild or moderate in severity, typical of any injected vaccine.

Other

Rarely, serious side effects such as allergic reactions, neurological disorders, and gastrointestinal disorders may occur following pneumococcal conjugate vaccination. 8 reported a case of erythema multiforme.

Side effects management

Injection site reactions

If you experience injection site reactions, applying a cool compress can help alleviate symptoms. Pain relievers can also be effective. If symptoms are severe, consult a healthcare professional.

Systemic reactions

If you experience systemic reactions such as fever, stay hydrated, rest, and monitor your symptoms. Consult a healthcare professional if symptoms are severe.

Other

If you suspect a serious side effect such as an allergic reaction, seek immediate medical attention.

Comparison across studies

Commonalities

Most studies indicate that pneumococcal conjugate vaccines have a high safety profile and strong immunogenicity. Additionally, side effects are generally mild and temporary, with serious side effects being rare.

Differences

The type and frequency of side effects observed following vaccination can vary between studies. This likely stems from variations in study participants' age, health status, vaccine type and formulation, and vaccination schedules.

Real-world application considerations

Pneumococcal conjugate vaccines are recommended for individuals at high risk of invasive pneumococcal disease. However, it's important to remember that even after vaccination, the risk of pneumococcal infection is not completely eliminated. Therefore, maintaining preventive measures like handwashing and gargling is crucial.

Limitations of current research

Research on pneumococcal conjugate vaccines is still ongoing. Further study is needed to evaluate long-term safety and efficacy, particularly.

Future research directions

Further research is needed to understand the long-term safety and efficacy of pneumococcal conjugate vaccines, their efficacy in diverse populations, the mechanisms behind side effects, and other aspects to enhance our understanding of this vaccine.

Conclusion

Pneumococcal conjugate vaccines are effective in preventing invasive pneumococcal disease. They demonstrate a high safety profile and strong immunogenicity. However, it's important to be aware of the potential for rare but serious side effects. Before vaccination, consult with your doctor to discuss any concerns and ensure you fully understand the necessary information before receiving the vaccine.

Literature analysis of 29 papers
Positive Content
29
Neutral Content
0
Negative Content
0
Article Type
11
2
0
2
29
1.

Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial.

Author: PanLu-Lu, GaoZhao, ZhouWei-Wei, LiMin-Jie, FangWen-Jian, JiWen-Juan, ZhaoYing, DuLin, ZhaoYu-Liang

Infant vaccine safety
Hypersensitivity

This phase I clinical trial evaluated the safety of the 15-valent pneumococcal conjugate vaccine (PCV15) in infants. The vaccine was generally well-tolerated, with most side effects being mild and transient, primarily fever and pain at the injection site. One case of hypersensitivity was reported.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

2.

Effects of message order and active participation on vaccine risk communication.

Author: OkunoHideo, SatohHiroshi, IitakeChie, HosokawaShinichi, OishiKazunori, KikkawaToshiko

Risk communication
Vaccine uptake

This study investigated the effects of message order, active participation, and their interactions on anticipated regret (AR) for vaccination.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Immune response to the hepatitis B antigen in the RTS,S/AS01 malaria vaccine, and co-administration with pneumococcal conjugate and rotavirus vaccines in African children: A randomized controlled trial.

Author: ValéaInnocent, AdjeiSamuel, UsufEffua, TraoreOusmane, AnsongDaniel, TintoHalidou, Owusu BoatengHarry, LeachAmanda, Mwinessobaonfou SomeAthanase, BuabengPatrick, VekemansJohan, NanaLouis Arnaud, KoteyAmos, VandoolaeghePascale, OuedraogoFlorence, SambianDavid, LievensMarc, TahitaMarc Christian, RettigTheresa, JongertErik, LompoPalpouguini, IdrissAli, BorysDorota, OuedraogoSayouba, PrempehFrank, HabibMd Ahsan, SchuermanLode, SorghoHermann, AgbenyegaTsiri

Malaria vaccine efficacy
Pneumococcal vaccine efficacy
Rotavirus vaccine efficacy
Fever
Pain

This study evaluated the immunogenicity and safety of co-administering the RTS,S/AS01 malaria vaccine with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) and human rotavirus vaccine (HRV) in African infants. Co-administration with RTS,S/AS01 did not compromise the immunogenicity of the co-administered vaccines, meeting non-inferiority criteria for PHiD-CV, HRV, and pertussis antigens. While some adverse events, such as pain and low-grade fever, were more frequent in the PHiD-CV group, no serious adverse events were considered vaccine-related. The study suggests that co-administering RTS,S/AS01 with pediatric vaccines is safe and immunologically acceptable.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Differences by sex in IgG levels following infant and childhood vaccinations: An individual participant data meta-analysis of vaccination studies.

Author: BoefAnna G C, van der KlisFiona R M, BerbersGuy A M, BuismanAnne-Marie, SandersElisabeth A M, KemmerenJeanet M, van der EndeArie, de MelkerHester E, RotsNynke Y, KnolMirjam J

Vaccination effectiveness
Sex-specific vaccination schedules

This study examined whether there are sex-related differences in immune responses to childhood vaccinations. It found no significant differences in antibody responses between boys and girls.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

6.

Pneumococcal conjugate vaccine 13 delivered as one primary and one booster dose (1 + 1) compared with two primary doses and a booster (2 + 1) in UK infants: a multicentre, parallel group randomised controlled trial.

Author: GoldblattDavid, SouthernJo, AndrewsNick J, BurbidgePolly, PartingtonJo, RoalfeLucy, Valente PintoMarta, ThalasselisVasilli, PlestedEmma, RichardsonHayley, SnapeMatthew D, MillerElizabeth

Increased antibody response

This study compared the post-booster antibody response in UK infants receiving a reduced priming schedule (1 + 1) of PCV13 vaccine versus the current 2 + 1 schedule. The aim was to assess the potential impact on population protection.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Immunogenicity and safety of single-dose, 13-valent pneumococcal conjugate vaccine in pediatric and adolescent oncology patients.

Author: HungTe-Yu, KotechaRishi S, BlythChristopher C, SteedSarah K, ThorntonRuth B, RyanAnne L, ColeCatherine H, RichmondPeter C

Prevent pneumococcal disease

This study discusses the benefit of the 13-valent pneumococcal conjugate vaccine (PCV13) in immunocompromised children with cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Erythema multiforme following pneumococcal vaccination.

Author: MonastirliAlexandra, PasmatziEfstathia, BadavanisGeorge, TsambaosDionysios

Reduced pneumococcal disorders
EM from PCV13

This study reports a rare case of Erythema Multiforme (EM) in a 2.5-year-old boy following pneumococcal vaccination (PCV13). Although the association between PCV13 and EM is not definitively confirmed, the evidence suggests a possible link, as other potential causes were ruled out.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults.

Author: SongJoon Young, CheongHee Jin, HyunHak Jun, SeoYu Bin, LeeJacob, WieSeong-Heon, ChoiMin Joo, ChoiWon Suk, NohJi Yun, YunJae Won, YunJin Gu, KimWoo Joo

Increased vaccine uptake

Concomitant administration of MF59-adjuvanted trivalent inactivated influenza vaccine (MF59-aTIV) and 13-valent pneumococcal conjugate vaccine (PCV13) showed no interference with antibody response and showed good safety profiles.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV).

Author: SilfverdalSven Arne, CoremansVanessa, FrançoisNancy, BorysDorota, CleerboutJan

Favorable benefit-risk
Well tolerated

This review evaluates the safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) based on 10 years of experience. The vaccine has been well tolerated in children aged less than 5 years, including those at higher risk for pneumococcal infection.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 18-49 years of age, naive to 23-valent pneumococcal polysaccharide vaccine.

Author: BryantK A, FrenckR, GurtmanA, RubinoJ, TreanorJ, ThompsonA, JonesT R, SundaraiyerV, BaxterL M, GruberW C, EminiE A, ScottD A, Schmoele-ThomaB

Pneumococcal conjugate vaccine

This study evaluated the immunogenicity, tolerability, and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in adults. PCV13 was found to be immunogenic, safe, and well-tolerated in both PPSV23-naive adults aged 60-64 years and adults aged 18-49 years.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Robust Vaccine Responses in Adult and Pediatric Cord Blood Transplantation Recipients Treated for Hematologic Malignancies.

Author: ShahGunjan L, ShuneLeyla, PurtillDuncan, DevlinSean, LauerEmily, LubinMarissa, BhattValkal, McElrathCourtney, KernanNancy A, ScaradavouAndromachi, GiraltSergio, PeralesMiguel A, PonceDoris M, YoungJames W, ShahMonica, PapanicolaouGenovefa, BarkerJuliet N

Vaccination after CBT
GVHD
Rituximab

Cord blood transplantation (CBT) recipients, including adults and those with prior graft-versus-host disease (GVHD), have similar vaccine response rates to adult donor allograft recipients. Vaccination in CBT recipients is recommended, as responses to tetanus, diphtheria, pertussis, Haemophilus influenzae, and polio were observed in children (86% to 100%) and adults (53% to 89%).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine compared to the 23-valent pneumococcal polysaccharide vaccine in elderly Japanese adults.

Author: ShiramotoMasanari, HanadaRyuzo, JuergensChristine, ShojiYasuko, YoshidaMizuki, BallanBarry, CooperDavid, GruberWilliam C, ScottDaniel A, Schmoele-ThomaBeate

Pneumococcal disease prevention
Local reactions
Systemic adverse events

PCV13 is safe and well-tolerated, and it elicits greater functional immune responses than PPSV23.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Health benefit for the child and promotion of the common good were the two most important reasons for participation in the FinIP vaccine trial.

Author: NieminenHeta, SyrjänenRitva K, PuumalainenTaneli, SirénPäivi, PalmuArto A

Pneumococcal vaccine effectiveness

A study of over 47,000 children found that parental concerns about the vaccine and its side effects, as well as the complexity of the study design, influenced their decision to participate in a pneumococcal vaccine trial.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

16.

Safety, tolerability, and immunogenicity of 7-valent pneumococcal conjugate vaccine in older infants and young children in China who are naive to pneumococcal vaccination: Results of a phase 4 open-label trial.

Author: LiRongcheng, HuangLirong, MoShunping, LiJunchun, ZhouXin, ChenZhangjing, LiangJohn, YoungMariano, GiardinaPeter C, ScottDaniel A

Robust immune response
Well tolerated
Pyrexia

PCV7 catch-up vaccinations given to previously unvaccinated older infants and young children in China resulted in a robust immune response to all 7 serotypes, which persisted after 1 year. PCV7 was well tolerated.

Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

Safety, reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children in the second year of life: Results from an open study.

Author: DickoAlassane, DickoYahia, BarryAmadou, SidibeYoussoufa, MahamarAlmahamoudou, SantaraGaoussou, DoloAmagana, DialloAminata, DoumboOgobara, ShafiFakrudeen, FrançoisNancy, YarzabalJuan Pablo, StrezovaAna, BorysDorota, SchuermanLode

Pneumococcal disease prevention

A 2-dose catch-up regimen of the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) was well-tolerated and immunogenic in Malian children. At least 94.7% of subjects had antibody concentrations ≥ 0.2 μg/ml for each vaccine pneumococcal serotype, except for serotypes 6B (82.5%) and 23F (87.7%).

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Safety, tolerability and immunogenicity of 15-valent pneumococcal conjugate vaccine in toddlers previously vaccinated with 7-valent pneumococcal conjugate vaccine.

Author: Sobanjo-ter MeulenAjoke, VesikariTimo, MalacamanEdgardo A, ShapiroSteven A, DallasMichael J, HooverPatricia A, McFetridgeRichard, StekJon E, MarcheseRocio D, HartzelJonathan, WatsonWendy J, MuseyLuwy K

Pneumococcal Disease Prevention

Pneumococcal conjugate vaccines (PCVs) are used to protect against pneumococcal disease. This article discusses the development and evaluation of a new 15-valent PCV (PCV15) in toddlers. PCV15 contains serotypes in PCV7 and 8 additional serotypes.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Antibody and plasmablast response to 13-valent pneumococcal conjugate vaccine in chronic lymphocytic leukemia patients--preliminary report.

Author: PasiarskiMarcin, RolinskiJacek, GrywalskaEwelina, Stelmach-GoldysAgnieszka, Korona-GlowniakIzabela, GozdzStanislaw, HusIwona, MalmAnna

Immune response enhancement
Pneumococcal infection prevention

This study aimed to compare the immune response to PCV13 in 24 previously untreated CLL patients and healthy subjects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults ≥ 50 years of age in Mexico.

Author: TinocoJuan Carlos, JuergensChristine, Ruiz PalaciosGuillermo M, Vazquez-NarvaezJorge, Enkerlin-PauwellsHermann Leo, SundaraiyerVani, PathiranaSudam, KalininaElena, GruberWilliam C, ScottDaniel A, Schmoele-ThomaBeate

Pneumococcal disease protection
Safety in adults
Strong immune response

This open-label multicenter clinical trial assessed the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 50 years of age not previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine (PPSV23).

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

21.

Safety and tolerability of 13-valent pneumococcal conjugate vaccine in the elderly.

Author: DurandoPaolo, RosselliRoberto, CremonesiIlaria, OrsiAndrea, AlbaneseErika, BarberisIlaria, PaganinoChiara, TrucchiCecilia, MartiniMariano, MarensiLorenzo, TurelloValter, Study GroupThe Ligurian Pneumococcal, BreganteAlessandro, CaccianiRoberto, IudiciRocco, La MarcaDiego, PedanoLeonardo, PetrucciAmadio Franco, SantoliniMaria, SbisàValentina, ZacconiMonica

Pneumococcal disease prevention

The European Medical Agency and the Food and Drug Administration have authorized the use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ≥50 years for the prevention of invasive pneumococcal diseases and community acquired pneumonia. The Liguria Region, in Italy, implemented an active and free of charge immunization strategy with PCV13 among adults with specific risk conditions and the elderly aged ≥70 years.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

Immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine as a booster dose in 12- to 18-month-old children primed with 3 doses of 7-valent pneumococcal conjugate vaccine.

Author: ThisyakornUsa, ChokephaibulkitKulkanya, KosalaraksaPope, BenjaponpitakSuwat, PancharoenChitsanu, ChuenkitmongkolSunate

Pneumococcal disease prevention

A randomized, controlled phase III study evaluated the immunogenicity and safety of PPV23 as a booster dose in toddlers primed with PCV7. Boosting with PPV23 was immunogenic and well tolerated, leading to higher antibody concentrations against certain serotypes compared to PCV7.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

23.

Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age.

Author: GadzinowskiJanusz, TanseySusan P, WysockiJacek, KopińskaElzbieta, Majda-StanisławskaEwa, CzajkaHanna, KorbalPiotr, PietrzykJacek J, BakerSherryl A, GiardinaPeter C, GruberWilliam C, EminiEmilio A, ScottDaniel A

Vaccine efficacy
Vaccine safety

Polysorbate 80 (P80) is a nonionic detergent used to solubilize proteins and is used in both oral and injectable medications, including vaccines. This study investigated the immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) with and without P80 before adding P80 to the formulation.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Pneumococcal conjugate vaccine administration during therapy for pediatric leukemia.

Author: CrawfordNigel W, BallochAnne, TikkanenLeena, MerchinaudFrancoise, DowniePeter, ButteryJim P

Pneumococcal vaccine safe
Satisfactory immune response
Invasive pneumococcal disease

Pediatric leukemia patients can safely receive PCV10 vaccine during chemotherapy. Most patients exhibited satisfactory serum immune responses for the majority of vaccine serotypes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

25.

A randomized study to evaluate the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, haemophilus influenzae b, and meningococcal serogroup C combination vaccine administered to infants at 2, 4 and 12 months of age.

Author: ThollotFranck, ScheifeleDavid, Pankow-CulotHeidemarie, CheuvartBrigitte, LeyssenMaarten, UlianovLiliana, MillerJacqueline M

Effective MenC and Hib responses

A phase II, randomized study compared the immunogenicity and safety of a heptavalent combination vaccine with licensed control vaccines in 480 infants. The study found that the heptavalent vaccine induced non-inferior MenC and Hib responses compared to control vaccines. Both vaccination regimens were immunogenic to all antigens but had lower-than-expected responses to poliomyelitis.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

26.

Randomized controlled study of the safety and immunogenicity of pneumococcal vaccine formulations containing PhtD and detoxified pneumolysin with alum or adjuvant system AS02V in elderly adults.

Author: PauksensKarlis, NilssonAnna C, CaubetMagalie, PascalThierry G, Van BellePascale, PoolmanJan T, VandepapelièrePierre G, VerlantVincent, VinkPeter E

Pneumococcal disease protection
Local and general symptoms

This study evaluated the safety, reactogenicity, and immunogenicity of six different pneumococcal vaccine formulations in adults aged 65 to 85 years. The vaccine formulations containing free or conjugated PhtD and dPly had acceptable reactogenicity and safety profiles.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

27.

Safety and immunogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian children: Booster dose and 2-dose catch-up regimens in the second year of life.

Author: OdusanyaOlumuyiwa O, KuyinuYetunde A, KehindeOmolara A, ShafiFakrudeen, FrançoisNancy, YarzabalJuan Pablo, DobbelaereKurt, RüggebergJens U, BorysDorota, SchuermanLode

Immunogenicity
Tolerability
Fever
Pain

A 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) booster dose or 2-dose catch-up was well tolerated and immunogenic for vaccine pneumococcal serotypes and protein D in Nigerian toddlers.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

28.

Post-licensure rapid immunization safety monitoring program (PRISM) data characterization.

Author: BakerMeghan A, NguyenMichael, ColeDavid V, LeeGrace M, LieuTracy A

Surveillance for vaccine safety

This study evaluated the capabilities of the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program, a system using electronic health information to monitor vaccine safety.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Evaluation StudyResearch that systematically evaluates the effectiveness of a particular program or policy. It measures its outcomes and provides important information for future decision-making.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

29.

Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in infants: a meta-analysis.

Author: Ruiz-AragónJ, Márquez PeláezS, Molina-LindeJ M, Grande-TejadaA M

Expanded protection
Pneumococcal vaccine
Local reactions

The 13-valent pneumococcal conjugate vaccine demonstrated similar safety and efficacy to the 7-valent vaccine, providing expanded protection against six additional serotypes. The vaccine was well tolerated and showed high immunogenicity for all tested serotypes, making it a valuable tool for preventing invasive pneumococcal disease in infants.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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