Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9 months of age a phase III randomised non-inferiority trial.

Wednesday, 28th of October 2015

Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9 months of age a phase III randomised non-inferiority trial.

Lalwani S¹ Chatterjee S² Balasubramanian S³ Bavdekar A⁴ Mehta S⁵ Datta S⁶ Povey M⁶ Henry O⁷.

 

Abstract

OBJECTIVE

This study (NCT00969436) compared the immunogenicity and safety of measles-mumps-rubella (MMR) followed by MMR+varicella (V) vaccines to (1) 2 doses of combined MMRV and (2) MMR followed by MMRV in Indian children.

DESIGN

Phase III open randomised non-inferiority study.

SETTING

6 tertiary care hospitals located in India.

PARTICIPANTS

Healthy participants aged 9-10 months not previously vaccinated against/exposed to measles mumps rubella and varicella or without a history of these diseases.

INTERVENTIONS

Participants were randomised (221) to receive 2 doses of either MMRV (MMRV/MMRV group) or MMR followed by MMRV (MMR/MMRV group) or MMR followed by MMR+V (MMR/MMR+V control group) at 9 and 15 months of age. Antibody titres against measles mumps and rubella were measured using ELISA and against varicella using an immunofluorescence assay.

MAIN OUTCOME MEASURES

To demonstrate non-inferiority of the 2 vaccination regimens versus the control in terms of seroconversion rates defined as a group difference with a lower bound of the 95% CI >-10% for each antigen 43 days postdose 2. Parents/guardians recorded solicited local and general symptoms for a 4-day and 43-day period after each vaccine dose respectively.

RESULTS

Seroconversion rates postdose 1 ranged from 87.5% to 93.2% for measles 83.3% to 86.1% for mumps and 98.7% to 100% for rubella across the 3 vaccine groups. The seroconversion rates postdose 2 were 100% for measles mumps and rubella and at least 95.8% for varicella across the 3 vaccine groups. Non-inferiority of MMRV/MMRV and MMR/MMRV to MMR/MMR+V was achieved for all antigens 43 days postdose 2. The 3 vaccination regimens were generally well tolerated in terms of solicited local and general symptoms.

CONCLUSIONS

The immune responses elicited by the MMRV/MMRV and MMR/MMRV vaccination regimens were non-inferior to those elicited by the MMR/MMR+V regimen for all antigens. The 3 vaccination schedules also exhibited an acceptable safety profile in Indian children.

TRIAL REGISTRATION NUMBER

NCT00969436.

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