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Phase 2 N=884 Randomized Prevention

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

Pneumococcal Infection

Enrolled (actual)
884
Serious AEs
2.8%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants Reporting Solicited Local and Systemic Adverse Events — 148; 153; 187; 213 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (Biological)
Age
Adult, Older Adult · 55+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Aug 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Reporting Solicited Local and Systemic Adverse Events
148; 153; 187; 213; 180; 214
PRIMARY
Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.
19; 14; 22
PRIMARY
Number of Participants Reporting Vaccine-related Serious Adverse Events.
0; 0; 0
PRIMARY
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
6.8; 20.9; 20.4; 216.0; 75.2; 95.1
SECONDARY
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
6.8; 20.9; 20.4; 93.4; 45.4; 54.4

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

Eligibility Criteria

Inclusion Criteria

  • Male or female adults 55 through 74 years of age at the time of enrollment who are able to provide informed consent. 2. For the pneumococcal vaccine-naïve group (Group I), no pneumococcal vaccine received prior to enrollment, as documented by participant report and review of available vaccine records. For the previously vaccinated group (Group II), documented vaccination with exactly one dose of PPSV23 administered >/=3 and 2 weeks) in the 30 through 59 days before vaccination should be excluded. (Topical, intranasal, and inhaled corticosteroids are allowed.) 6. Serious chronic disorders including active or metastatic malignancy, hematologic malignancy, severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the opinion of the investigator precludes the subject's participation. 7. Known HIV, hepatitis B or hepatitis C infection. 8. Residence in a nursing home or other skilled nursing facility or requirement for skilled nursing care. An ambulatory subject who does not require skilled nursing care and is a resident of a retirement home or community is eligible for the trial. 9. Inability to provide informed consent or complete study activities, for example, due to dementia or other impairment. 10. Poor or missing eyesight, requiring third party support to read. 11. Receipt of any blood products, including immunoglobulin, within three months prior to enrollment. 12. Heart rate less than 40 bpm or greater than 120 bpm as measured at the enrollment visit and prior to vaccination. 13. Systolic blood pressure less than 90 mm Hg or greater than 170 mm Hg as measured at the enrollment visit and prior to vaccination. 14. Diastolic blood pressure greater than 110 mm Hg as measured at the enrollment visit and prior to vaccination. 15. For Group I, unable to receive a vaccination in the deltoid muscle of the right arm and unable to receive a vaccination in the deltoid muscle of the left arm because of insufficient muscle mass, need to avoid injections due to prior lymph node dissection or radiation, or other factor. For Group II, unable to receive a vaccination in the deltoid muscle of one or both arms because of insufficient muscle mass, need to avoid injections due to prior lymph node dissection or radiation, or other factor. 16. Currently on anticoagulant therapy (for example, warfarin, heparin [IV or SQ], or dabigatran) or a history of bleeding diathesis that would contraindicate intramuscular injection. (Aspirin, clopidogrel, dipyridamole, and nonsteroidal anti-inflammatory agents are allowed). 17. Known clinically significant allergic reaction to prior pneumococcal vaccination (for Group II participants) or to a component of PCV13 vaccine (PCV13 is latex free). 18. Current known abuse of alcohol or drug addiction that in the opinion of the Investigator may interfere with the subject's ability to comply with trial procedures. 19. Rec eipt of any other investigational vaccine or agent within one month before enrollment or intent to receive any other investigational vaccine or agent prior to the conclusion of the study. 20. Any medical condition that would, in the opinion of the investigator, place the participant at an unacceptable risk of an adverse event or interfere with the evaluation of the study objectives.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01654263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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