Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02547649
Other study ID # V114-006
Secondary ID V114-006
Status Completed
Phase Phase 2
First received
Last updated
Start date October 8, 2015
Est. completion date January 20, 2016

Study information

Verified date April 2019
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants

≥50 years of age in good health.


Recruitment information / eligibility

Status Completed
Enrollment 690
Est. completion date January 20, 2016
Est. primary completion date January 20, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Good health; any underlying chronic illness must be documented to be in stable condition

- Highly unlikely to conceive through 6 weeks after administration of the study vaccine

Exclusion Criteria:

- Prior administration of any pneumococcal vaccine

- History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease

- Known hypersensitivity to any vaccine component

- Known or suspected impairment of immune function

- Received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination

- Coagulation disorder contraindicating intramuscular vaccination

- Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease

- Received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.

- Participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study

- Breast feeding

- User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
V114-A
Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
V114-B
Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
Prevnar 13®
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose.

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 Participants With an Adverse Event (AE) The percentage of participants experiencing =1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Up to 14 days after vaccination
Primary Percentage of Participants With a Solicited Injection-site Adverse Event (AE) The percentage of participants experiencing =1 solicited injection-site AE(s) in each arm was determined. Up to 14 days after vaccination
Primary Percentage of Participants With a Solicited Systemic Adverse Event (AE) The percentage of participants experiencing =1 solicited systemic AE(s) in each arm was determined. Up to 14 days after vaccination
Primary Percentage of Participants With a Serious Adverse Event (SAE) The percentage of participants experiencing =1 SAE(s) in each arm was determined. Up to 30 days after vaccination
Primary Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE) The percentage of participants experiencing =1 vaccine-related SAEs(s) in each arm was determined. Up to 30 days after vaccination
Primary Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA). Day 30 (one month after vaccination)
Secondary Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination The IgG GMCs of each common pneumococcal serotype (CS) and V114-specific pneumococcal serotype (VS) were determined for each arm. Concentrations were determined with pneumococcal electrochemiluminescence (PnECL). Day 30 (one month after vaccination)
Secondary Percentage of Participants With a =4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs) The percentage of participants with =4-fold rise from baseline in OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model. Baseline and Day 30 (one month after vaccination)
Secondary Percentage of Participants With a =4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies The percentage of participants with =4-fold rise from baseline in IgG GMCs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model. Baseline and Day 30 (one month after vaccination)
See also
  Status Clinical Trial Phase
Completed NCT02201030 - Immunogenicity and Safety Study of NBP606 in Healthy Infants Phase 3
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Completed NCT04031846 - Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) Phase 3
Recruiting NCT05920499 - The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage N/A
Completed NCT01215175 - Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001) Phase 1
Completed NCT02892812 - A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults Phase 1
Completed NCT02116998 - Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae Phase 2
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01193582 - A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria Phase 4
Completed NCT00744263 - Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults Phase 4
Completed NCT00492557 - Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults Phase 3
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Completed NCT00137605 - Early Versus Delayed Pneumococcal Vaccination in HIV Phase 1/Phase 2
Completed NCT00205803 - Study Evaluating Pneumococcal Vaccine in Healthy Infants Phase 1/Phase 2
Completed NCT02531373 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005) Phase 1/Phase 2
Completed NCT03615482 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU) Phase 3
Completed NCT03565900 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM) Phase 3
Completed NCT04989465 - A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine Phase 4
Completed NCT02573181 - Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007) Phase 2
Completed NCT05477693 - Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine Phase 4