Evaluation of humoral immune response induced by a supplemental dose of inactivated poliovirus vaccine (IPV) administered intradermally or intramuscularly versus a dose of monovalent type 1 oral poliovirus vaccine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90744784

Enrollment

1000

Registered

2008-11-26

Start date

2009-01-10

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Poliomyelitis Infections and Infestations Other viral encephalitis, not elsewhere classified

Interventions

1. Intervention group one: one fractional dose of IPV by GSK (0.1 ml or 1/5 of a dose) 2. Control group one: a full dose of IPV (0.5 ml) by GSK 3. Control group two: a full dose of IPV (0.5 ml) by Pa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy children in the target group (6 - 9 months at baseline, either sex) 2. Resident in Moradabad district, Uttar Pradesh, India

Exclusion criteria

Exclusion criteria: Children with chronic illness

Design outcomes

Primary

Measure	Time frame
1. To evaluate whether intradermal administration of one-fifth of the standard IPV dose provides seroconversion rates and titres against all 3 serotypes comparable with the full 0.5 ml IPV dose administered intramuscularly 2. To determine whether IPV induces higher seroconversion rates and antibody titres (significant booster effect) to type 1 poliovirus compared to mOPV 1 in infants 6 - 9 months of age who have been exposed to several OPV doses 3. To characterise the immune response of the trial vaccination as primary (priming) or secondary (boosting), through measurement of antibody titres reached at 7 days and through determination of immunoglobulin A and M by ELISA	—

Measure

Time frame

1. To evaluate whether intradermal administration of one-fifth of the standard IPV dose provides seroconversion rates and titres against all 3 serotypes comparable with the full 0.5 ml IPV dose administered intramuscularly 2. To determine whether IPV induces higher seroconversion rates and antibody titres (significant booster effect) to type 1 poliovirus compared to mOPV 1 in infants 6 - 9 months of age who have been exposed to several OPV doses 3. To characterise the immune response of the trial vaccination as primary (priming) or secondary (boosting), through measurement of antibody titres reached at 7 days and through determination of immunoglobulin A and M by ELISA

—

Secondary

Measure	Time frame
1. To assess whether one dose of IPV manufactured by Panacea administered intramuscularly elicits the same immune response as one dose of IPV manufactured by GlaxoSmithKline (both with 40-8-32 D antigen potency) 2. To assess whether Sanofi-Pasteur mOPV1, with 4-fold higher vaccine virus dosage compared to Panacea mOPV1, induces higher seroconversion rates and antibody titres to poliovirus type 1 than Panacea mOPV1	—

Measure

Time frame

1. To assess whether one dose of IPV manufactured by Panacea administered intramuscularly elicits the same immune response as one dose of IPV manufactured by GlaxoSmithKline (both with 40-8-32 D antigen potency) 2. To assess whether Sanofi-Pasteur mOPV1, with 4-fold higher vaccine virus dosage compared to Panacea mOPV1, induces higher seroconversion rates and antibody titres to poliovirus type 1 than Panacea mOPV1

—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026