FindTrial
Sign In

Safety and immunogenicity of concomitant administration of a virosomal hepatitis A vaccine (Epaxal®) with DTP, aHib, IPV, OPV and MMR vaccines versus non-concomitant administration in 12 to 15 month-old children

Safety and immunogenicity of concomitant administration of a virosomal hepatitis A vaccine (Epaxal®) with DTP, aHib, IPV, OPV and MMR vaccines versus non-concomitant administration in 12 to 15 month-old children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82277382
Enrollment
300
Registered
2006-03-10
Start date
2004-12-26
Completion date
Unknown
Last updated
2021-01-25

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

Conditions

Hepatitis A Infections and Infestations Hepatitis A

Interventions

1. Epaxal® and concomitant administration of DTP, aHib, IPV, OPV and MMR vaccines 2. Epaxal® followed by DTP, aHib, IPV, OPV and MMR vaccines one month later 3. Compara

Sponsors

Berna Biotech Ltd (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy children between 12 and 15 months old at the time of vaccination

Exclusion criteria

Exclusion criteria: 1. Children that have not received three documented doses of DTP, aHib and polio vaccines during infancy 2. Children that have received a documented dose of MMR during infancy 3. Previous vaccination against hepatitis A 4. Any confirmed or suspected immunosuppressive or immunodeficient condition

Design outcomes

Primary

MeasureTime frame
Percentage of subjects seroprotected (anti-HAV titre >/=10 mIU/ml) one month after vaccination—

Secondary

MeasureTime frame
1. Percentage of subjects with antibodies against each co-administered antigen one month after vaccination 2. Incidence of adverse events reported after each vaccination—

Countries

Israel

Outcome results

None listed

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