Contact information
Type
Scientific
Contact name
Dr Tracey Goodman
ORCID ID
Contact details
World Health Organization
20
Avenue Appia
Geneva-27
CH-1211
Switzerland
-
goodmant@who.int
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
WHO/RPC041
Study information
Scientific title
Assessment of serological responses to Hepatitis B and Hib vaccines in infants receiving vitamin A (Ghana)
Acronym
Study hypothesis
Hypothesis:
The simultaneous administration of vitamin A with the pentavalent vaccine may reduce or enhance the serological response to Hepatitis B and Haemophilus influenzae type b vaccines in infants.
Aim:
To evaluate the seroconversion rates of administering the pentavalent vaccine with vitamin A supplements using two different supplementation regimes. That is:
1. Supplementation of mothers with 400,000 IU vitamin A at 6 weeks in two divided doses and supplementation of children with 50,000 IU vitamin A at 6,10 and 14 weeks
2. Supplementation of mothers alone with 400,000 IU vitamin A at 6 weeks in two divided doses
Specific objectives:
1. To measure the antibody response to Hepatitis B vaccination and Haemophilus influenza type b vaccination in infants given 50,000 IU of vitamin A at 6,10 and 14 weeks and whose mothers were given 400,000 IU of vitamin A at 6 weeks post partum
2. To measure the antibody response to Hepatitis B vaccination and Haemophilus influenza type b vaccination in infants whose mothers only were given 400,000 IU of vitamin A at 6 weeks post partum
3. To assess the impact of vitamin A given to infants at the time of vaccination (6, 10, and 14 weeks) on the seroconversion rates of Hepatitis B and Haemophilus influenza b vaccines
Ethics approval(s)
Ethics approval received from the World Health Organization (WHO) Secretariat Committee on Research Involving Human Subjects (SCRIHS) - conditional approval received on 12th December 2003, amendments approved on 6th April 2007.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Prevention
Patient information sheet
Condition
Immunology/vaccines
Intervention
Treatment group:
1. Mothers at 6 weeks: 200,000 IU Vitamin A x 2 (day 1 and day 2)
2. Infants at 6, 10 and 14 weeks: 50,000 IU Vitamin A and Diphtheria, Pertussis, Tetanus (DPT), Hepatitis B (HepB) and Haemophilus influenzae type b (Hib) vaccines
Control group:
1. Mothers 200,000 IU Vitamin A x 2 (day 1 and day 2)
2. Infants: DPT, HepB and Hib alone
Intervention type
Supplement
Primary outcome measure
The impact of the different doses of vitamin A on the pentavalent vaccines will be assessed by comparing the two groups in terms of their seroconversion rates for:
1. Hepatitis B
2. Haemophilus influenzae type b
The choice of four months for reevaluation is because this is the age at which it is presently recommended to determine the seroconversion rates. Accordingly, pre-samples will be taken at 6 weeks prior to DPT-HepB Hib immunisation and post samples will be taken at 1 month after the DPT-HepB Hib immunisation.
Secondary outcome measures
No secondary outcome measures
Overall study start date
01/01/2004
Overall study end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Live-born infants
2. Willingness of mothers to participate in the study
3. Must reside in the study area for at least 4 months after the birth
4. Consent to two blood samples before and after their child's vaccination
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
1042 mother-infant pairs.
Total final enrolment
1077
Participant exclusion criteria
Does not comply with above inclusion criteria
Recruitment start date
01/01/2004
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Ghana, Switzerland
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Sponsor details
20
Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/05/2007 | Yes | No |