Article Text

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
  1. Sanjay Lalwani1,
  2. Sukanta Chatterjee2,
  3. Sundaram Balasubramanian3,
  4. Ashish Bavdekar4,
  5. Shailesh Mehta5,
  6. Sanjoy Datta6,
  7. Michael Povey6,
  8. Ouzama Henry7
  1. 1Department of Pediatrics, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
  2. 2Department of Pediatrics, Medical College Kolkata, Kolkata, West Bengal, India
  3. 3Kanchi Kamakoti Childs Trust Hospital, Chennai, Tamil Nadu, India
  4. 4Department of Pediatrics, KEM Hospital, Pune, Maharashtra, India
  5. 5GSK Pharmaceuticals Ltd., Mumbai, Maharashtra, India
  6. 6GSK Vaccines, Wavre, Belgium
  7. 7GSK Vaccines, King of Prussia, Philadelphia, USA
  1. Correspondence to Dr Sanjay Lalwani; sanjaylalwani2007{at}rediffmail.com

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 (2:2:1) 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.

  • immunogenicity
  • India
  • measles-mumps-rubella-varicella vaccine
  • safety
  • vaccination schedule

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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