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Assessment of serological responses to Hepatitis B and Hib vaccines in infants receiving vitamin A (Ghana)

Assessment of serological responses to Hepatitis B and Hib vaccines in infants receiving vitamin A (Ghana)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28820504
Enrollment
1042
Registered
2004-09-22
Start date
2004-01-01
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunology/vaccines Infections and Infestations Vaccination again disease

Interventions

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, Teta

Sponsors

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

Eligibility

Inclusion 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

Exclusion criteria: Does not comply with above inclusion criteria

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

Ghana, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026