NCT01654263

A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

A Phase IIb, Open-Label, Dose-Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 884 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 55 Years – 74 Years
• Healthy volunteers: Accepted

Summary

The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two groups of participants (55 through 74 years of age). First group vaccine naïve participants will be open-label to receive a single injection of 0.5 mL PCV13. Second group of participant previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) will be randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each arm (Group IIA or Group IIB). Blood samples will be obtained at baseline, at one month and six months post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study

Detailed description

This is a phase IIb open-label immunogenicity and safety study to evaluate dosages of 0.5 mL and 1.0 mL (given as two 0.5 mL injections in separate arms) of PCV13 in adults 55 through 74 years of age previously vaccinated with PPSV23. The study will enroll two groups of participants. Group I participants will all receive an open-label dose of 0.5 mL PCV13 and will include 294 adults 55-74 years of age who have not previously received 23-valent pneumococcal polysaccharide vaccine (PPSV23). Group II will be randomized 1:1 to receive 0.5 mL PCV13 (Group IIA) or 0.5 mL PCV13 in the right arm and 0.5 mL PCV 13 in the left arm (Group IIB). Group II will include 588 adults 55 through 74 years of age who previously received a single dose of PPSV23 \> /=3 years and \< /=7 years prior to enrollment. Enrollment in both groups will be stratified by age group (55 through 64 years and 65 through 74 years).The study duration is approximately 18 months. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study vaccination, and is non-inferior to 12 vaccine serotypes; and determine if two 0.5 mL doses of PCV13 administered to participants previously vaccinated with PPSV23 are non-inferior to a single dose of 0.5 mL of PCV13 administered to vaccine-naïve adults 55 through 74 years of age for the 12 vaccine serotypes, as measured by serotype-specific OPA titers 28 days after study vaccination. The secondary objectives of this study are to: determine if two x 0.5mL doses of PCV13 is statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 180 days after study vaccination, and is non-inferior to 12 vaccine serotypes; to determine if two x 0.5mL doses of PCV13 administered to participants previously vaccinated with PPSV23 is non-inferior to a single dose of 0.5 mL of PCV13 administered to vaccine-naïve adults 55 through 74 years of age for 12 vaccine serotypes, as measured by serotype-specific OPA titers 180 days after study vaccination. Parent protocol to sub-study 12-0031.

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]	Prevnar 13 (PCV13) 13-valent pneumococcal conjugate vaccine. All doses given on Day 0. Group IA and IB (open-label): 0.5 mL intramuscular (IM) injection; Group IIA (open-label, randomized): 0.5 mL IM injection; Group IIB (open-label, randomized): 0.5 mL IM injection in the right arm and 0.5 mL IM in the left arm.

Timeline

• Start date: 2012-10-10
• Primary completion: 2015-08-21
• Completion: 2015-08-21
• First posted: 2012-07-31
• Last updated: 2017-03-27
• Results posted: 2017-01-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study