Randomized Controlled Trial of Measles Vaccination Schedule

NCT03170765 | Unknown DMC

• 1 other identifier: LM/PED/01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Measles is a preventable infectious viral disease. Since 1985, India has been administering a single dose of measles vaccine to all infants at 9 months of age. This age was chosen to balance the disappearance of maternal (transplacental) antibodies with the increasing risk of developing measles. Thus infants are expected to get protection against measles by acquired maternal measles antibodies derived trans-placentally from the mother for the first 9 months of life. Thereafter vaccine-induced antibodies are expected to protect infants. Seroconversion after measles vaccination does not take place as long as maternal measles antibodies persist in the infant. However, it is widely recognized that a substantial proportion of measles infection (10 to 15%) can occur among infants before the age of measles vaccination. Further, two small cohort studies done in our institution confirm that the majority of infants lose maternal antibodies by six months of age, making them susceptible to measles.This argues strongly for anticipating measles vaccination to an earlier age. However, such early vaccination has the risk that residual maternal antibodies (even if insufficient to protect infants) can neutralize the antigen in the vaccine, rendering vaccination ineffective. Therefore, a careful balance has to be chosen so that low levels of circulating maternal antibodies do not interfere with infants' response to vaccination. However, there is no prospective study in Indian infants to determine the seroconversion and sero-protection rate of earlier vaccination. This study has following aims and objectives:

1. 1.To study the level of measles specific immunoglobulin G (IgG) antibodies in a cohort of term infants followed from birth to 9 months of age; and the pattern of antibody decline in them.
2. 2.To compare the levels of antibodies in infants at these time points and correlate the levels with the antibody level in the respective mothers at the time of delivery.
3. 3.To compare the efficacy and safety of three different measles vaccination schedules in a cohort of term infants viz (i) vaccination at 9 months of age (current practice), (ii) vaccination at 7.5 months and 9 months of age, and (iii) vaccination at 6 months and 9 months of age.

Conditions

MEASLES DISEASE

Outcome Measures

Primary Outcomes (1)

• Proportion of protected infants from measles.

  Infants with serum anti measles IgG antibody levels higher than 200 m IU/ml, or other specific values provided by manufacturers in the antibody kits, will be taken as protected.

  6 weeks after vaccination

Secondary Outcomes (7)

• Incidence of treatment - emergent adverse events

  3 days after vaccination

• Infant- Mother antibody correlation at birth

  At birth

• Infant- Mother antibody correlation at 3 months

  At 3 months of age

• Infant- Mother antibody correlation at 6 months

  At 6 months of age

• Susceptibility among not vaccinated infants

  Birth to 12 months of age

Study Arms (3)

GROUP A

EXPERIMENTAL

measles vaccine at 6 months and 9 months of age

Biological: Measles vaccine

GROUP B

EXPERIMENTAL

measles vaccine at 7.5 months and 9 months of age

Biological: Measles vaccine

GROUP C

ACTIVE COMPARATOR

measles vaccine at 9 months of age (current practice)

Biological: Measles vaccine

Interventions

Measles vaccine BIOLOGICAL

Live attenuated measles vaccine of brands currently being used in National Immunization Schedule of India.

GROUP A; GROUP B; GROUP C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Infants born to mothers known to have known immunodeficiency determined through examination of clinical records (HIV positive and those on immunosuppressive therapy during pregnancy).
• Babies born with antenatally or postnatally diagnosed congenital anomalies that are anticipated to be life-threatening.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Measles

Interventions

Measles Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• LAXMI MAKAM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• JOSEPH L MATHEW

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY DIRECTOR

• SOURABH DUTTA

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

• VANITA SURI

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

• R K RATHO

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

• BHAVNEET BHARTI

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

• MINI P SINGH

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants are infants ranging from 6-9 months of age. They are expected to be unaware of the intervention. The laboratory personnel performing the antibody level measurements will be blinded by sending the samples with only a four digit code that does not reveal the intervention received.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: JUNIOR RESIDENT, DEPARTMENT OF PEADIATRICS

Model Details: THREE ARM RCT

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 31, 2017
• Study Start: March 14, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 31, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)