Condition category
Infections and Infestations
Date applied
04/08/2004
Date assigned
22/09/2004
Last edited
26/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tracey Goodman

ORCID ID

Contact details

World Health Organization
20
Avenue Appia
Geneva-27
CH-1211
Switzerland
goodmant@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/RPC041

Study information

Scientific title

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

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

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Vitamin A supplementation

Primary outcome measures

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 trial start date

01/01/2004

Overall trial end date

31/12/2006

Reason abandoned

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

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1042 mother-infant pairs.

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

Trial 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

http://www.who.int

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17449592

Publication citations

  1. Results

    Newton S, Owusu-Agyei S, Ampofo W, Zandoh C, Adjuik M, Adjei G, Tchum S, Filteau S, Kirkwood BR, Vitamin A supplementation enhances infants' immune responses to hepatitis B vaccine but does not affect responses to Haemophilus influenzae type b vaccine., J. Nutr., 2007, 137, 5, 1272-1277.

Additional files

Editorial Notes