Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)

Safety, Tolerability and Immunogenicity of Pneumovax 23 (V110) in Healthy Adults in India

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00496093

Enrollment

133

Registered

2007-07-04

Start date

2005-10-31

Completion date

2006-01-31

Last updated

2017-03-14

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

Conditions

Pneumococcal Infection

Brief summary

To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India.

Detailed description

This was an open-label non-randomized study to assess the safety and immunogenicity of PNEUMOVAXTM 23 in healthy adults in India. The participants enrolled in this study were healthy Indian adults, 50 years of age or older, with no prior history of having received a pneumococcal vaccination (14-valent or 23-valent) and no prior history of Pneumococcal disease. All participants enrolled in the study received one 0.5 mL dose of PNEUMOVAXTM 23 by intramuscular (deltoid) injection on Day 1. Serum samples were obtained prior to vaccination on Day 1 and on Day 28 (+/-7 days) postvaccination. The duration of participation for each participant was approximately one month, with the study completion at the Day 28 postvaccination bleed and return of the Vaccination Report Card (VRC). Enrollment was completed within approximately 2 months. The last postvaccination blood sample was collected within 3 months of study initiation.

Interventions

BIOLOGICALPneumococcal Vaccine, Polyvalent (23-valent)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy indian adults of 50 years of age * In good health; any underlying chronic illness must be documented to be in stable condition * Signed and dated informed consent prior to receipt of the study vaccine

Exclusion criteria

* Functional or anatomic asplenia * History of auto immune disease * Hypersensitivity to any of the components of the study vaccine,including phenol * Known or suspected immune dysfunction, including persons with congenital immunodeficiency * Prior vaccination with any pneumococcal vaccine

Design outcomes

Primary

Measure	Time frame
Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b	post-vaccination

Secondary

Measure	Time frame
Any AE within 15 days after vaccination, with particular attention to injection site AE and fever	15 days after vaccination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026