A Clinical study of Pentavalent vaccine

A Phase IV clinical trial to assess the persistence of immunity in children who received DTwP-HB-Hib vaccine (adsorbed) during primary vaccination series and evaluation of immunogenicity & reactogenicity of booster dose of DTwP/Hib vaccine of Serum Institute of India Ltd, Pune.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000665

Enrollment

300

Registered

2009-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: DTP/ Hib vaccine (Quadrovax): A booster single dose of 0.5 ml administered intra-muscularly in children aged 15-24 months Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: ï?·Children who received DTwP-HB-Hib vaccine (adsorbed) manufactured by Serum Institute of India Ltd. or Panacea Biotec Ltd. during primary vaccination series during Phase III clinical trial (Protocol ID:DTPw-HB-Hib/SIIL/07/2007). ï?·Age 15 ? 24 months. ï?·Parents willing for participation of their child in the study and sign written informed consent.

Exclusion criteria

Exclusion criteria: History of receipt of booster dose of any of the components of vaccine. History of significant and/or persistent neurological/ developmental disorder or hematological, hepatic, renal, cardiac, respiratory disease.  Child under immunosuppressive therapy  History of allergic reaction to any vaccine.  Receipt of any other vaccine during the study period with exception of Oral Polio Vaccine (OPV) & Measles Mumps and Rubella (MMR) vaccine. Administration of immunoglobulins or any blood products since birth. Axillary temperature  38C. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Major congenital or hereditary immunodeficiency. Simultaneous participation in any other clinical study.

Design outcomes

Primary

Measure	Time frame
Pre booster IgG antibody titres against D, T, Pw, HB and Hib, and percentage seroprotection/ vaccine response. Post booster IgG antibody titres against D, T, Pw and Hib, and percentage seroprotection/ vaccine response.Timepoint: Pre-booster antibody levels will be assessed in children coming for booster vaccination at 15-24 months and thereafter vaccinated. Post-booster Ab levels will be assessed after one month following vaccination.	—

Measure

Time frame

Pre booster IgG antibody titres against D, T, Pw, HB and Hib, and percentage seroprotection/ vaccine response. Post booster IgG antibody titres against D, T, Pw and Hib, and percentage seroprotection/ vaccine response.Timepoint: Pre-booster antibody levels will be assessed in children coming for booster vaccination at 15-24 months and thereafter vaccinated. Post-booster Ab levels will be assessed after one month following vaccination.

—

Secondary

Measure	Time frame
Adverse events (solicited and unsolicited) occurring after booster dose of the vaccine.Timepoint: Adverse events will be captured until one month following booster dose of DTP/ Hib (Quadrovax) vaccine.	—

Countries

India

Contacts

Public ContactDr Hitt Sharma

Serum Institute Of India Ltd

drhjs@seruminstitute.com02026602451

Outcome results

None listed

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