PCV10 Reactogenicity and Immunogenicity Study - Malindi

NCT01028326 | Unknown Phase 4

• 1 other identifier: SSC 1635
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The World Health Organization has recommended that developing countries should incorporate pneumococcal conjugate vaccine (PCV) into their routine immunization schedules. The Kenya Ministry of Health anticipates introducing a new formulation of PCV, PCV10, into the routine childhood immunization schedule in 2010. In the areas of Kenya that have been designated to monitor the impact of vaccine, a catch-up campaign will be implemented to vaccinate children aged 12-59 months. PCV10 has been found to be safe and effective in infants. It is licensed for use in children up to 2 years of age, but its use as a primary series in children over age 12 months has not been evaluated. This study will assess the immunogenicity and reactogenicity of PCV10 first administered at an age of 12-59 months.

Conditions

Pneumococcal Pneumonia

Keywords

Pneumococcal pneumonia vaccine

Outcome Measures

Primary Outcomes (1)

• Serotype-specific anti-pneumococcal antibody responses to vaccination

  Day 0, 30, 90, 210

Secondary Outcomes (3)

• Serotype-specific NP carriage of pneumococci

  Day 0, 30, 60, 90, 180

• Vaccine reactogenicity

  Day 0, 3

• Immunological memory responses

  Day 0, 30, 90, 210

Study Arms (3)

Group A

EXPERIMENTAL

Group A of children will receive 2 doses of PCV10 vaccine, one at the time of enrolment and one 2 months later, followed by a dose of DTaP vaccine 4 months later

Biological: PCV10 and DTaP

Group B

EXPERIMENTAL

Group B of children will receive PCV10 vaccine, followed by a dose of DTaP vaccine after 2 months, and another dose of PCV10 4 months later.

Biological: PCV10 and DTaP

Group C

ACTIVE COMPARATOR

Group C of children will receive a dose of hepatitis A vaccine, followed by a dose of DTaP vaccine after 2 months, and another dose of hepatitis A 4 months later, along with a dose of PCV10.

Biological: hepatitis A vaccine, DTaP, PCV10

Interventions

PCV10 and DTaP BIOLOGICAL

A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 60 and a 0.5 mL intramuscular dose of DTaP on day 180.

Also known as: Synflorix

Group A

hepatitis A vaccine, DTaP, PCV10 BIOLOGICAL

A nurse will administer a 0.5mL intramuscular dose of hepatitis A vaccine on day 0 and day 180; a 0.5 mL intramuscular dose of DTaP on day 60; and a 0.5 mL dose of PCV10 on day 180.

Also known as: Synflorix

Group C

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 12-59 months
• Written informed consent

You may not qualify if:

• Current febrile illness (temperature \>38.5°C)
• Previous receipt of any pneumococcal vaccine
• Previous receipt of a DTP-containing vaccine after the 1st year of life
• Previous receipt of hepatitis A vaccine
• Severe malnutrition (mid upper arm circumference \<11.5 cm) or other serious medical condition (e.g., malignancy, AIDS, tuberculosis)
• Seizures within the previous 6 months or progressive neurological illness
• Known allergies to vaccines or vaccine components
• Resident in the Kilifi Demographic Surveillance area
• Intention to leave the study area in the next 6 months

Sponsors & Collaborators

• KEMRI-Wellcome Trust Collaborative Research Program: lead
• Kenya Ministry of Health: collaborator
• University of Oxford: collaborator
• University of Colorado, Denver: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Malindi District Hospital

Malindi, Coast, Kenya

Location

Related Publications (2)

• Feazel LM, Santorico SA, Robertson CE, Bashraheil M, Scott JA, Frank DN, Hammitt LL. Effects of Vaccination with 10-Valent Pneumococcal Non-Typeable Haemophilus influenza Protein D Conjugate Vaccine (PHiD-CV) on the Nasopharyngeal Microbiome of Kenyan Toddlers. PLoS One. 2015 Jun 17;10(6):e0128064. doi: 10.1371/journal.pone.0128064. eCollection 2015.

  PMID: 26083474 DERIVED

• Hammitt LL, Ojal J, Bashraheil M, Morpeth SC, Karani A, Habib A, Borys D, Goldblatt D, Scott JA. Immunogenicity, impact on carriage and reactogenicity of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Kenyan children aged 1-4 years: a randomized controlled trial. PLoS One. 2014 Jan 21;9(1):e85459. doi: 10.1371/journal.pone.0085459. eCollection 2014.

  PMID: 24465570 DERIVED

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Interventions

10-valent pneumococcal conjugate vaccine; PHiD-CV vaccine; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Laura Hammitt, MD

  Oxford University, KEMRI-Wellcome Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2018
• Last Updated: February 23, 2018

Record last verified: 2017-07

Locations

KE (1)