A comparison of booster immunisation with a combination DTPa-IPV vaccine or DTPa plus IPV in separate injections when
H Marshall1, T Nolan, D Roberton
1Department of Paediatrics, Children's Youth and Women's Health Service and University of Adelaide, SA, Australia. helen.marshall@adelaide.edu.au
Insights
GSK
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Childhood immunization schedules typically include boosters for diphtheria, tetanus, acellular pertussis, and poliovirus.
- The second dose of the measles, mumps, and rubella (MMR) vaccine is usually administered between 4-6 years of age.
- Evaluating combined vaccine administration is crucial for optimizing vaccination schedules and reducing patient burden.
Purpose of the Study:
- To assess the immunogenicity and reactogenicity of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTPa-IPV) vaccine.
- To compare this combined vaccine with separate DTPa and IPV injections when co-administered with the MMR vaccine.
- To determine if the combined DTPa-IPV vaccine impacts the immunogenicity of the MMR vaccine.
Main Methods:
- A randomized study involving 362 children aged 4-6 years, previously primed with DTPa, OPV, and MMR vaccines.
- Participants received either a combined DTPa-IPV vaccine or separate DTPa and IPV injections, both concomitantly with the MMR vaccine.
- Antibody levels were measured before and one month after vaccination to assess immunogenicity.
Main Results:
- Both vaccine regimens induced seroprotective antibody levels against diphtheria, tetanus, and poliovirus.
- High vaccine responses were observed for pertussis antigens (PT, FHA, PRN) and seropositivity for measles, mumps, and rubella.
- Local reactions, such as swelling, were common but the DTPa-IPV combination did not increase adverse events compared to separate injections.
- The immunogenicity of the MMR vaccine was unaffected by the co-administration of either DTPa-IPV or DTPa+IPV.
Conclusions:
- The combined DTPa-IPV vaccine is immunogenic as a booster dose in children aged 4-6 years.
- It demonstrates a similar reactogenicity profile to the DTPa vaccine when administered separately.
- Co-administration of the DTPa-IPV vaccine with the MMR vaccine does not compromise the immunogenicity of either vaccine.
Abstract:
This study evaluated GSK's combined DTPa-IPV vaccine (Infanrix-IPV) given as a fifth consecutive acellular pertussis booster dose in conjunction with the second dose of MMR vaccine (Priorix) in children aged 4-6 years. The immunogenicity and reactogenicity of this vaccine regimen was compared with separate injections of DTPa and IPV when given concomitantly with MMR. A cohort of 362 children previously primed with four doses of DTPa and OPV, and a single dose of MMR were randomized to receive either DTPa-IPV+MMR (N=181) or DTPa+IPV+MMR (N=181). Antibody concentrations were measured prior to and 1 month after the booster dose. After immunisation all subjects from both groups had seroprotective antibody levels against diphtheria, tetanus and the three poliovirus serotypes, > or = 96% showed vaccine response to PT, FHA and PRN, all were seropositive to mumps and rubella, and all but one subject were seropositive to measles. Immunogenicity results for each component antigen were similar for DTPa-IPV and separately co-administered DTPa and IPV. Local reactions were common with 24.0% and 31.1% of children experiencing swelling >50mm at the DTPa-IPV and DTPa injection sites, respectively. The DTPa-IPV combination did not increase the incidence or intensity of adverse events compared with separately administered DTPa+IPV. The response to the concomitantly administered MMR vaccine was similar in the two groups and similar to previously reported responses for a second dose of MMR. This combined DTPa-IPV vaccine has a similar reactogenicity profile to DTPa, is immunogenic when given as a booster dose at 4-6 years of age, and has no impact on the immunogenicity of a co-administered second dose of MMR vaccine.
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