Immunogenicity of neonatal schedules of oral rotavirus vaccines (Rotavac, Rotasil, RotaTeq and Rotarix)

A Phase IV, Open-labelled, Randomized, Controlled Study to Assess the Immunogenicity of neonatal schedules of oral rotavirus vaccines (Rotavac, Rotasiil, RotaTeq, Rotarix,) as compared to infant schedules in Healthy Indian infants. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087056

Enrollment

1200

Registered

2025-05-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

None listed

Interventions

Intervention1: Neonatal schedule of Rotavac, Rotasil, RotaTeq and Rotarix: Neonatal schedule of Rotavac, Rotasil, RotaTeq and Rotarix will be administered at birth followed by WHO recommended infant d

Eligibility

Inclusion criteria

Inclusion criteria: Age 0-5 days at the time of enrollment. Birth weight more than or equal to 2500 grams. Born full term (more than or equal to 37 weeks of gestation) Healthy neonates as established by medical history and clinical examination. Parent who intends to remain in the area with the child during the study period.

Exclusion criteria

Exclusion criteria: Any acute illness at the time of enrolment (temporary exclusion). Concurrent participation in another clinical trial during study period. Prior receipt of rotavirus vaccine or intent to receive rotavirus vaccine outside the study clinic Presence of significant systemic disorder as determined by medical history and/or physical examination. Major congenital or genetic defect. Receipt of immunoglobulin therapy and/or blood products since birth or planned administration during the study period. Any medical or social condition that in the opinion of the PI may interfere with the protocol adherence or pose a risk to the participant.

Design outcomes

Primary

Measure	Time frame
Proportion of seroresponders defined as participants with anti-rotavirus IgA antibody concentration more than or equal to 20 U/mL four weeks after the last dose of the neonatal schedule of RVV as compared to WHO recommended infant schedules (at 18 weeks for Rotavac, Rotasiil and RotaTeq and at 14 weeks for Rotarix).Timepoint: Proportion of seroresponders defined as participants with anti-rotavirus IgA antibody concentration more than or equal to 20 U/mL four weeks after the last dose of the neonatal schedule of RVV as compared to WHO recommended infant schedules (at 18 weeks for Rotavac, Rotasiil and RotaTeq and at 14 weeks for Rotarix).	—

Measure

Time frame

Proportion of seroresponders defined as participants with anti-rotavirus IgA antibody concentration more than or equal to 20 U/mL four weeks after the last dose of the neonatal schedule of RVV as compared to WHO recommended infant schedules (at 18 weeks for Rotavac, Rotasiil and RotaTeq and at 14 weeks for Rotarix).Timepoint: Proportion of seroresponders defined as participants with anti-rotavirus IgA antibody concentration more than or equal to 20 U/mL four weeks after the last dose of the neonatal schedule of RVV as compared to WHO recommended infant schedules (at 18 weeks for Rotavac, Rotasiil and RotaTeq and at 14 weeks for Rotarix).

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Secondary

Measure	Time frame
Geometric mean concentration (GMC) of anti-rotavirus IgA antibodies four weeks after the last dose of the neonatal schedule of RVV as compared to WHO recommended infant schedules (at 18 weeks for Rotavac, Rotasiil and RotaTeq and at 14 weeks for Rotarix).Timepoint: At 18 weeks for Rotavac, Rotasiil and RotaTeq and at 14 weeks for Rotarix;Proportion of seroresponders and IgA GMC at 14 weeks of age after receiving neonatal RVV 3-doses of Rotavac, Rotasiil and RotaTeq as compared to the levels at 18 weeks of age after receiving neonatal RVV 4-doses schedule of the respective vaccines in a one-third subset of participants.Timepoint: At 14 weeks (4 weeks after 3-doses of neonatal schedule for Rotavac, Rotasiil and RotaTeq vs at 18 weeks (4 weeks after 4-doses of neonatal schedule for Rotavac, Rotasiil, RotaTeq);3. Proportion of seroresponders and IgA GMC at 10 weeks of age after neonatal RVV 2-doses in Rotarix group as compared to the levels at 14 weeks after completing neonatal RVV 3-doses schedule of Rotarix in a one-third subset of participants.Timepoint: At 10 weeks (4 weeks after 2-doses of Rotarix) compared to 14 weeks (4 weeks after 3-doses of Rotarix);Proportion of seroresponders and IgA GMC at 14 weeks of age after receiving neonatal RVV 3-doses (0, 6, & 10) of Rotavac, Rotasiil and RotaTeq as compared to 2-doses (6 & 10 weeks) of the respective WHO recommended infant schedules in a one-third subset of participants.Timepoint: At 14 weeks (4 weeks after 3-doses of neonatal schedule for Rotavac, Rotasiil and RotaTeq vs at 14 weeks (4 weeks after 2-doses of WHO schedule for Rotavac, Rotasiil, RotaTeq);5. Proportion of seroresponders and IgA GMC at 10 weeks of age after neonatal RVV 2-doses (0 & 6) in Rotarix group as compared to a single dose of Rotarix at 6 weeks in a one-third subset of participantsTimepoint: At 10 weeks (4 weeks after 2-doses of neonatal schedule of Rotarix compared to a single dose of Rotarix at 6 weeks;Proportion of seroresponders and IgA GM	—

Measure

Time frame

Geometric mean concentration (GMC) of anti-rotavirus IgA antibodies four weeks after the last dose of the neonatal schedule of RVV as compared to WHO recommended infant schedules (at 18 weeks for Rotavac, Rotasiil and RotaTeq and at 14 weeks for Rotarix).Timepoint: At 18 weeks for Rotavac, Rotasiil and RotaTeq and at 14 weeks for Rotarix;Proportion of seroresponders and IgA GMC at 14 weeks of age after receiving neonatal RVV 3-doses of Rotavac, Rotasiil and RotaTeq as compared to the levels at 18 weeks of age after receiving neonatal RVV 4-doses schedule of the respective vaccines in a one-third subset of participants.Timepoint: At 14 weeks (4 weeks after 3-doses of neonatal schedule for Rotavac, Rotasiil and RotaTeq vs at 18 weeks (4 weeks after 4-doses of neonatal schedule for Rotavac, Rotasiil, RotaTeq);3. Proportion of seroresponders and IgA GMC at 10 weeks of age after neonatal RVV 2-doses in Rotarix group as compared to the levels at 14 weeks after completing neonatal RVV 3-doses schedule of Rotarix in a one-third subset of participants.Timepoint: At 10 weeks (4 weeks after 2-doses of Rotarix) compared to 14 weeks (4 weeks after 3-doses of Rotarix);Proportion of seroresponders and IgA GMC at 14 weeks of age after receiving neonatal RVV 3-doses (0, 6, & 10) of Rotavac, Rotasiil and RotaTeq as compared to 2-doses (6 & 10 weeks) of the respective WHO recommended infant schedules in a one-third subset of participants.Timepoint: At 14 weeks (4 weeks after 3-doses of neonatal schedule for Rotavac, Rotasiil and RotaTeq vs at 14 weeks (4 weeks after 2-doses of WHO schedule for Rotavac, Rotasiil, RotaTeq);5. Proportion of seroresponders and IgA GMC at 10 weeks of age after neonatal RVV 2-doses (0 & 6) in Rotarix group as compared to a single dose of Rotarix at 6 weeks in a one-third subset of participantsTimepoint: At 10 weeks (4 weeks after 2-doses of neonatal schedule of Rotarix compared to a single dose of Rotarix at 6 weeks;Proportion of seroresponders and IgA GM

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Countries

India

Contacts

Public ContactDr Ashish Bavdekar

KEM Hospital Research Centre

a.bavdekar@kemhrcpune.org02066037342

Outcome results