Comparison of the immunogenicity and safety of pentavalent vaccine Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus single-dose vials in healthy infants: a phase 3, open-label, randomized, parallel-group, non-inferiority study

Capeding, María Rosario; Alberto, Edison; Versteilen, Amanda; Rauscher, Martina; Bagchi, Partha; Palacios, Patricia

doi:10.1016/j.ijid.2016.02.015

Cited by 4 publications

(4 citation statements)

References 18 publications

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“…The ultimate goal of vaccination for public health is to prevent bacterial and viral infections. The Pentavalent vaccine is expected to reduce the procedural steps, vaccination process time, storage needs, and to minimize vaccine wastage as compared to conventional administration with a syringe (2). In the present study, the immunogenicity of the Pentavalent vaccine was evaluated in addition to the comparison of antibody titers before and after three doses and evaluating its complications and side effects in vaccinated infants.…”

Section: Discussionmentioning

confidence: 99%

“…Immunization, as a cost-effective and life-saving intervention, is a fundamental component of public health policies for controlling infectious diseases (1,2). Nowadays, multivalent vaccines like the tetravalent (DTP-Hib or DTP-HepB) or the Pentavalent (DTP-HepB-Hib) combination vaccines have been added to the immunization program in many countries (3).…”

Section: Introductionmentioning

confidence: 99%

“…The prospect of up to six or seven separate injections at each visit for an infant is stressful for parents (4). Numerous advantages are documented for combined vaccines including decrease in the number of clinic visits, protection against several diseases in one injection, better immunization coverage, simple, easy-to-administer fully liquid formulations, fewer injections and less distress for children, lower shipping and transport costs, fewer syringes and an increase in parental consent (1,2,4). Therefore, the addition of antigens to existing vaccines with high coverage is considered an effective and appropriate strategy for protecting society from new diseases (5).…”

Section: Introductionmentioning

confidence: 99%

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Immunogenicity and Complications of the Pentavalent Vaccine in Iranian Children

et al. 2021

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Objective: Vaccination is one of the most convenient and safe preventive care measures available for children. The Pentavalent vaccine which protects against five major infections including diphtheria, tetanus, pertussis, hepatitis B(HepB) and Haemophilus influenzae type b(Hib) was added to the Iranian national immunization program in November 2014. This study aimed to determine the Pentavalent vaccine adverse events and immunogenicity in an Iranian children population in Sari, northern Iran.Method: In this descriptive-analytical study, children who were vaccinated with three doses of the Pentavalent vaccine were studied. Two venous blood samples were obtained before the first dose and 4 weeks following the last booster dose. Possible local and systemic complications of the vaccine were recorded until 7 days following vaccination. Antibody titers were measured by quantitative ELISA kits and geometric mean titer(GMT) was calculated for each vaccine component before and after 3 doses of vaccine. Statistical analysis was performed by SPSS 20.0 software and Chi-square and Fisher's exact tests were used for analysis.Results: Immunogenicity of the Pentavalent vaccine for tetanus was 100%(GMT:2.52 Eu/mL, 95%CI: 2.22–2.88), Hib 98.7%(GMT:2.44 Eu/mL, 95%CI: 2.06–2.89), HepB 98.7%(GMT:153.54 Eu/mL, 95%CI: 133.73–176.29), diphtheria 93.1%(GMT:0.43 Eu/mL, 95%CI:0.37–0.51) and pertussis were 63.7% (GMT:19.44 Eu/mL, 95%CI:16.42–23.03). The most common systemic complication after vaccination was fever. Also, one infant cried for more than 3 hours after the second dose. Other serious side effects were not observed.Conclusion: The Pentavalent vaccine used in Iran can cause adequate antibody response against diphtheria, tetanus, pertussis, Hib and hepatitis B in most cases with minimal side effects. The immunogenicity of this vaccine is significantly lower for pertussis. In this study, no severe complication leading to contraindication to subsequent injections was reported. So, the present policy in replacing triple DTP vaccine with Pentavalent vaccine should be continued in Iran.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Immunogenicity and Complications of the Pentavalent Vaccine in Iranian Children

et al. 2021

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“…Several other researchers have also investigated the safety of pentavalent vaccines in diverse settings. Bavdekar et al [30], Angela et al [31], Dodoo et al [32], Sharma et al [33], Asturias et al [34], Maria et al [35], and Manoochehr et al [36] conducted studies across various populations. These studies predominantly identified non-serious AEFIs, which typically resolved with or without medication.…”

Section: Introductionmentioning

confidence: 99%

Pentavalent Vaccine: How Safe Is It Among Infants Accessing Immunization In Nigerian Health Facilities

Elemuwa,

Ehijie,

Elemuwa

et al. 2024

Preprint

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Rationale: Pentavalent vaccines offer significant public health benefits by protecting against five major diseases with a single injection. However, concerns have been raised in various studies regarding potential associations between combined vaccines and conditions such as autism, febrile seizures, sudden unexpected death in infancy, demyelinating disorders, and neurodevelopmental disorders. Objective: This study aimed to evaluate the safety of pentavalent vaccines administered to infants aged between 6 and 14 weeks. Methods: A total of 423 infants, all aged 6 weeks and receiving their first pentavalent vaccine at selected healthcare facilities, were recruited for the study after obtaining informed consent from their mothers or caregivers. The infants were administered three doses of the vaccine at 6, 10, and 14 weeks. Mothers and caregivers were provided with diaries and thermometers to monitor and record any Adverse Events Following Immunization (AEFI) observed in their babies after each vaccine dose. Follow-up was conducted through telephone calls to ensure accurate monitoring and recording of any identified events. Results: The study identified various AEFIs in the infants following their routine immunizations. These included pain at the injection site, fever, swelling at the injection site, vomiting, refusal to feed, excessive crying, coughing, rash, stooling, restlessness, and severe local reactions. Fever was the most commonly reported systemic AEFI, with incidence rates decreasing from 66.98% after the first dose to 55.37% after the third dose. Pain and swelling at the injection site were the most frequently reported local AEFIs, with their incidence also decreasing from the first to the third doses. No statistically significant differences were observed in the occurrence of AEFIs across the three doses. Conclusions: The pentavalent vaccine was found to be safe for infants in the Federal Capital Territory (FCT), Nigeria, with the observed AEFIs being generally mild and decreasing in frequency with subsequent doses. Recommendations: Further studies should be conducted to monitor long-term safety and potential rare adverse effects of pentavalent vaccines. Additionally, public health education should emphasize the safety and benefits of pentavalent vaccines to increase vaccination rates and reduce vaccine hesitancy. Significance Statement: This study underscores the safety of pentavalent vaccines in infants, reinforcing their role in preventing multiple serious diseases through a single immunization schedule. The findings support the continued use and promotion of pentavalent vaccines in public health programs, particularly in regions with high infant mortality rates and limited healthcare resources.

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Glycoconjugate Vaccines for Prevention of Haemophilus influenzae Type b Diseases

Khatuntseva

Nifantiev

2021

Russ J Bioorg Chem

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Comparison of the immunogenicity and safety of pentavalent vaccine Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus single-dose vials in healthy infants: a phase 3, open-label, randomized, parallel-group, non-inferiority study

Abstract: Quinvaxem in cPAD was non-inferior to single-dose vial with respect to seroprotection/seroconversion rates for all antibodies. Both presentations were well-tolerated.

Cited by 4 publications

References 18 publications

Immunogenicity and Complications of the Pentavalent Vaccine in Iranian Children

Immunogenicity and Complications of the Pentavalent Vaccine in Iranian Children

Pentavalent Vaccine: How Safe Is It Among Infants Accessing Immunization In Nigerian Health Facilities

Glycoconjugate Vaccines for Prevention of Haemophilus influenzae Type b Diseases

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