Assessment of serological responses to Hepatitis B and Hib vaccines in infants receiving vitamin A (Ghana)
| ISRCTN | ISRCTN28820504 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28820504 |
| Secondary identifying numbers | WHO/RPC041 |
- Submission date
- 04/08/2004
- Registration date
- 22/09/2004
- Last edited
- 10/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Tracey Goodman
Scientific
Scientific
World Health Organization
20, Avenue Appia
Geneva-27
CH-1211
Switzerland
| goodmant@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Assessment of serological responses to Hepatitis B and Hib vaccines in infants receiving vitamin A (Ghana) |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 1042 mother-infant pairs. |
| Total final enrolment | 1077 |
| Key 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 |
| Key exclusion criteria | Does not comply with above inclusion criteria |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Ghana
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Research organisation
Research organisation
20, Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | 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 |
Editorial Notes
10/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
