Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine co-administered with a booster dose of a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine in healthy children aged 12–23 months

Abstract

This study was undertaken to assess the co-administration of an experimental measles-mumps-rubella-varicella vaccine (MMRV, GlaxoSmithKline Biologicals) with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate (DTPa-HBV-IPV/Hib) vaccine in healthy children. Healthy children aged 12-23 months (N = 451) were randomised to one of three parallel groups to receive one dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine (co-administration group), or one dose of MMRV vaccine alone (MMRV group), or a booster dose of DTPa-HBV-IPV/Hib vaccine alone (DTPa-HBV-IPV/Hib group). No differences in seroconversion rates for measles (>95%), mumps (>80%), rubella (>99%) and varicella (>98%) were seen between the co-administration group and the MMRV group. No differences in geometric mean titres (GMTs) were observed between the two groups with the exception of anti-measles titres, which were observed to be higher in the MMRV group than in the co-administration group (4,419.2 vs. 3,441.8 mIU/ml respectively). Immune response to the booster dose of DTPa-HBV-IPV/Hib vaccine was observed to be similar in the co-administration group and the DTPa-HBV-IPV/Hib group. Co-administration of the MMRV vaccine with a booster dose of DTPa-HBV-IPV/Hib vaccine was well-tolerated and did not exacerbate the reactogenicity profile of either vaccine. In summary, GlaxoSmithKline Biologicals' experimental MMRV vaccine was immunogenic and well-tolerated when administered with a booster dose of DTPa-HBV-IPV/Hib vaccine during the second year of life. The ability to co-administer the MMRV vaccine at the same time as other routine childhood immunisation vaccines could increase compliance with varicella vaccination in countries where this vaccine is already recommended and may facilitate implementation of varicella vaccination elsewhere.

Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella vaccine to children aged 11–21 months

“…The tolerability results for both IM and SC groups in this study were comparable to previous studies of MMRV vaccine for local reactions of pain, redness and swelling [25,30,33]. The subjects vaccinated in the present study also had a similar incidence of 'any fever' from days 0 to 42 after dose 1 (IM group, 72.9%; SC group, 70.4%) to subjects of a similar age vaccinated in other studies, where the incidence of 'any fever' ranged from 67.7% to 78.0% [25,33,37]. The present study confirms results from previous studies in which the second dose was given in the second year of life [18,19,38] and supports the shorter vaccination schedules now endorsed by the WHO, which are expected to result in better compliance.…”

“…Seroconversion rate for measles were 99.3% in the IM group (one out of 138 subject seronegative) and 98.6% in the SC group (two out of 140 subjects seronegative). The high seroconversion rates (approaching or equal to 100% after two doses) and GMTs for all components support similarly high rates observed in previous studies using this MMRV vaccine [11,25,30,32,33,37].…”

“…Priorix-Tetra™ (GlaxoSmithKline Biologicals) is a combined MMRV vaccine with an immunogenicity profile similar to separately administered MMR + V vaccines and a high degree of antibody persistence [11,18,25,30,32,37]. Live attenuated vaccines such as the MMRV vaccine are usually given subcutaneously, whereas most paediatric vaccines are inactivated vaccines and typically given intramuscularly.…”

Complete DNA Sequences of Two Oka Strain Varicella-Zoster Virus Genomes

“…Combined vaccine products containing the VZV Oka strain have been developed as well. For instance, GSK Biologicals and Merck & Co., Inc., developed combined tetravalent measlesmumps-rubella-varicella vaccines (Priorix-Tetra and ProQuad, respectively), providing the benefits of measles-mumps-rubella and varicella vaccination in a single injection (19,30,35,48,71,72,79).…”

Risk of febrile seizure after measles–mumps–rubella–varicella vaccine: A systematic review and meta-analysis

“…Twenty-three clinical trials were published and the others [26,27] were unpublished. Twenty-nine clinical trials [26][27][28][29][30][31][32][33][34][35][37][38][39][40][41][42][43][44][45][46][47][48][49][50] reported the incidence of febrile seizure or vaccine related febrile seizure within 0-28, 0-42 or 0-56 days (0-28/42/56 days) after first MMRV vaccine dose in healthy children aged 9-24 months, twenty-five of them [26][27][28][29][30][33][34][35][37][38][39][40][41][42][43][45][46][47][48][49][50] also reported the incidence within a smaller risk window of 7 to 10 days (7-10 days) after vaccination. Children in 17 clinical trials …”