A Phase IV study to assess the effect of reduced two dose schedule (1+1) of Pneumococcal Conjugate Vaccines.

A Phase IV, Open labelled, Randomized, Controlled Study to Assess the Immunogenicity and Effect on Pneumococcal Nasopharyngeal Carriage of reduced two dose schedule (1+1) of Pneumococcal Conjugate Vaccines 10-valent PNEUMOSIL and 14 valent PNEUBEVAX-14 as compared to their recommended three dose schedule (2+1) in Healthy Indian Infants. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077626

Enrollment

1400

Registered

2024-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None listed

Interventions

Intervention1: Reduced two dose schedules (1+1) of PCV-10 (PNEUMOSIL) and PCV-14 (PNEUBEVAX-14): The reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® (14 weeks and 9 months) will be adm

Eligibility

Inclusion criteria

Inclusion criteria: Healthy infants as established by medical history and clinical examination 6-8 weeks (42-56 days) of age at the time of enrolment. Written informed consent obtained from the parent(s) of infants Parent who intends to remain in the study area with the child during the study period and will be ready to comply with the protocol.

Exclusion criteria

Exclusion criteria: Presence of fever on the day of enrolment (=38.0oC) (temporary exclusion) Any acute illness at the time of enrolment (temporary exclusion) Concurrent participation in another clinical trial during study period. Weight-for-height z-score =-3SD Presence of significant systemic disorder as determined by medical history and/or physical examination Prior receipt of any pneumococcal vaccine Known sensitivity or allergy to any components of the study vaccine Major congenital or genetic defect Receipt of any immunoglobulin therapy and/or blood products since birth or planned administration during the study period. History of chronic administration (defined as more than 14 days) of immune-suppressants including corticosteroids. 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
To compare the immunogenicity response with reduced two dose schedule (1+1) of PNEUMOSIL and PNEUBEVAX-14® as compared to their recommended three dose schedule (2 + 1) at 10 months of age (four weeks after the booster dose) in healthy Indian infants.Timepoint: 10 months of age	—

Secondary

Measure	Time frame
To compare the functional serotype specific antibody response as measured by opsonophagocytic assay (OPA) with reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® as compared to their regular three dose (2+1) at 10 months of age (4 weeks after the booster dose) in healthy Indian infants.Timepoint: At 10 months of age;To assess the impact of reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® on nasopharyngeal carriage of vaccine serotypes (VTs) of S. pneumoniae at 15 months of age (6 months after receipt of the booster dose) as compared to their recommended three dose schedule (2+1) in healthy Indian infants.Timepoint: At 15 months of age	—

Measure

Time frame

To compare the functional serotype specific antibody response as measured by opsonophagocytic assay (OPA) with reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® as compared to their regular three dose (2+1) at 10 months of age (4 weeks after the booster dose) in healthy Indian infants.Timepoint: At 10 months of age;To assess the impact of reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® on nasopharyngeal carriage of vaccine serotypes (VTs) of S. pneumoniae at 15 months of age (6 months after receipt of the booster dose) as compared to their recommended three dose schedule (2+1) in healthy Indian infants.Timepoint: At 15 months of age

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Countries

India

Contacts

Public ContactDr Ashish Bavdekar

KEM Hospital Research Centre

a.bavdekar@kemhrcpune.org02066037342

Outcome results