ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	21 November 2022
Main ID:	ISRCTN28820504
Date of registration:	22/09/2004
Prospective Registration:	No
Primary sponsor:	World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Public title:	Assessment of serological responses to Hepatitis B and Hib vaccines in infants receiving vitamin A (Ghana)
Scientific title:	Assessment of serological responses to Hepatitis B and Hib vaccines in infants receiving vitamin A (Ghana)
Date of first enrolment:	01/01/2004
Target sample size:	1042
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN28820504
Study type:	Interventional
Study design:	Randomised controlled trial (Prevention)
Phase:	Not Specified

Countries of recruitment
Ghana	Switzerland

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Tracey Goodman
Address:	World Health Organization 20, Avenue Appia CH-1211 Geneva-27 Switzerland
Telephone:	-
Email:	goodmant@who.int
Affiliation:

Key inclusion & exclusion criteria

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

Exclusion criteria: Does not comply with above inclusion criteria

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Immunology/vaccines
Infections and Infestations
Vaccination again disease

Intervention(s)

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

Primary Outcome(s)

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(s)

No secondary outcome measures

Secondary ID(s)

WHO/RPC041

Source(s) of Monetary Support

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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.

Results

Results available:	Yes
Date Posted:
Date Completed:	31/12/2006
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.