A Randomized, Controlled Trial to Assess the Immunogenicity and Safety of a Heptavalent Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Hib and Meningococcal Serogroup C Combination Vaccine Administered at 2, 3, 4 and 12–18 Months of Age

Szenborn, Leszek; Czajka, Hanna; Brzostek, Jerzy; Konior, Ryszard; Caubet, Magalie; Ulianov, Liliana; Leyssen, Maarten

doi:10.1097/inf.0b013e31828d6b20

Cited by 8 publications

(3 citation statements)

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“…Children received vaccines according to 1 of 4 schedules: 6, 10, and 14 weeks; 2, 3, and 4 months; 2, 4, and 6 months, or 3, 4, and 5 months. Studies were conducted in Europe (Spain France, Germany, Greece, Poland Czech Republic, Finland), Africa (Mali and Nigeria), Latin America (Chile, Nicaragua, Argentina, Dominican Republic) East Asia (The Philippines and Korea), Russia, and Australia …”

Section: Resultsmentioning

confidence: 99%

The Influence of Maternally Derived Antibody and Infant Age at Vaccination on Infant Vaccine Responses

et al. 2017

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The design of infant immunization schedules requires an understanding of the factors that determine the immune response to each vaccine antigen.DATA SOURCES Deidentified individual participant data from GlaxoSmithKline clinical trials were obtained through Clinical Study Data Request. The data were requested on January 2, 2015, and final data were received on April 11, 2016.STUDY SELECTION Immunogenicity trials of licensed or unlicensed vaccines administered to infants were included if antibody concentrations in infants were measured prior to the first dose of vaccine.DATA EXTRACTION AND SYNTHESIS The database was examined; studies that appeared to have appropriate data were reviewed. MAIN OUTCOMES AND MEASURESAntigen-specific antibody concentration measured 1 month after priming vaccine doses, before booster vaccination, and 1 month after booster vaccine doses.RESULTS A total of 7630 infants from 32 studies in 17 countries were included. Mean (SD) age at baseline was 9.0 (2.3) weeks; 3906 (51.2%) were boys. Preexisting maternal antibody inhibited infant antibody responses to priming doses for 20 of 21 antigens. The largest effects were observed for inactivated polio vaccine, where 2-fold higher maternal antibody concentrations resulted in 20% to 28% lower postvaccination antibody concentration (geometric mean ratios [GMRs], type 1: 0.80; 95% CI, 0.78-0.83; type 2: 0.72; 95% CI, 0.69-0.74; type 3: 0.78; 95% CI, 0.75-0.82). For acellular pertussis antigens, 2-fold higher maternal antibody was associated with 11% lower postvaccination antibody for pertussis toxoid (GMR, 0.89; 95% CI, 0.87-0.90) and filamentous hemagglutinin (GMR, 0.89; 95% CI, 0.88-0.90) and 22% lower pertactin antibody (GMR, 0.78; 95% CI, 0.77-0.80). For tetanus and diphtheria, these estimates were 13% (GMR, 0.87; 95% CI, 0.86-0.88) and 24% (GMR, 0.76; 95% CI, 0.74-0.77), respectively. The influence of maternal antibody was still evident in reduced responses to booster doses of acellular pertussis, inactivated polio, and diphtheria vaccines at 12 to 24 months of age. Children who were older when first immunized had higher antibody responses to priming doses for 18 of 21 antigens, after adjusting for the effect of maternal antibody concentrations. The largest effect was seen for polyribosylribitol phosphate antibody, where responses were 71% higher per month (GMR, 1.71; 95% CI, 1.52-1.92). CONCLUSIONS AND RELEVANCEMaternal antibody concentrations and infant age at first vaccination both influence infant vaccine responses. These effects are seen for almost all vaccines contained in global immunization programs and influence immune response for some vaccines even at the age of 24 months. These data highlight the potential for maternal immunization strategies to influence established infant programs.

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Section: Resultsmentioning

confidence: 99%

The Influence of Maternally Derived Antibody and Infant Age at Vaccination on Infant Vaccine Responses

et al. 2017

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“…Simultaneous administration of more than one vaccine using different anatomical sites helps to reduce the number of visits and increases compliance with the recommended immunisation schedule. Moreover, several studies have demonstrated that administering these two vaccines at the same time did not interfere with the infant's immune responses and did not dramatically increase reactogenicity . To resolve paediatricians' doubts about providing more than one vaccine at a time, targeted information on the safety and immunogenicity of vaccine co‐administration needs to be provided to reduce the chance of missed opportunities for vaccinations.…”

Section: Discussionmentioning

confidence: 99%

Paediatricians require more information before they routinely co‐administer the meningococcal B vaccine with routine infant vaccines

et al. 2015

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“…Although vaccine studies have reported on the attitudes towards the electroporation procedure itself [6,9], they have done so across participants in aggregate; none have examined attitudes in the same participants over the course of a series of vaccinations. Most vaccinations will require multiple doses to achieve optimal immunogenicity and efficacy [10,11]. Therefore, it is important to explore individual participants' attitudes to the level of pain and its acceptability as a series of procedures; strong negative perceptions could impact a patient's willingness to be vaccinated or return for a full vaccination series.…”

Section: Introductionmentioning

confidence: 99%

Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial

et al. 2020

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A Randomized, Controlled Trial to Assess the Immunogenicity and Safety of a Heptavalent Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Hib and Meningococcal Serogroup C Combination Vaccine Administered at 2, 3, 4 and 12–18 Months of Age

Abstract: The heptavalent vaccine was immunogenic and had a clinically acceptable safety profile when administered to infants and toddlers.

Cited by 8 publications

References 27 publications

The Influence of Maternally Derived Antibody and Infant Age at Vaccination on Infant Vaccine Responses

The Influence of Maternally Derived Antibody and Infant Age at Vaccination on Infant Vaccine Responses

Paediatricians require more information before they routinely co‐administer the meningococcal B vaccine with routine infant vaccines

Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial

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