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

Pneumococcal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496093
• Other study ID #: V110-011
• Secondary ID: 2007_018
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2007
• Last updated: March 13, 2017
• Start date: October 2005
• Est. completion date: January 2006

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Infection
• Pneumococcal Infections

Intervention

Biological:
• Pneumococcal Vaccine, Polyvalent (23-valent)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Any AE within 15 days after vaccination, with particular attention to injection site AE and fever		15 days after vaccination