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Completed

NCT Number: NCT02531373

A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

2 month–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult Cohort: 18 to 49 years and in good health

  • Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.

Infant Cohort: approximately 2 months (42 to 90 days) and in good health.

Exclusion criteria

Adult cohort: Prior administration of any pneumococcal vaccine

  • History of invasive pneumococcal disease
  • Known hypersensitivity to any vaccine component
  • Known or suspected impairment of immune function
  • Coagulation disorder contraindicating intramuscular vaccination
  • Received a blood transfusion or blood products within 6 months
  • Participated in another clinical study of an investigational product within 2 months
  • Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
  • Known hypersensitivity to any vaccine component
  • Known or suspected impairment of immune function
  • History of congenital or acquired immunodeficiency
  • Has or mother has documented Human Immunodeficiency virus (HIV) infection
  • Has or mother has documented hepatitis B surface antigen positive result
  • Functional or anatomic asplenia
  • History of failure to thrive
  • Coagulation disorder contraindicating intramuscular vaccination
  • History of autoimmune disease or autoimmune disorder
  • Known neurologic or cognitive behavioral disorder
  • Received systemic corticosteroids within 14 days
  • Received other licensed non-live vaccine within 14 days
  • Received other licensed live virus vaccine within 30 days
  • Received a blood transfusion or blood products
  • Participated in another clinical study of an investigational product
  • History of invasive pneumococcal disease

Treatment and study plan

V114 Medium Dose

Biological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

V114 High Dose

Biological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose

V114 Medium Dose with Alternative Carrier Protein

Biological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose

V114 High Dose with Alternative Carrier Protein

Biological

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose

Prevnar 13™

Biological

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

Primary outcomes

  1. Adults: Percentage of Participants With an Adverse Event

    Time frame: Up to 6 weeks after vaccination

    An adverse event (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. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

  2. Infants: Percentage of Participants With an Adverse Event

    Time frame: Up to 1 month after Vaccination 4 (Month 11-15)

    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. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

  3. Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event

    Time frame: Up to time of Vaccination 4 (Month 10-13)

    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. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

  4. Infants: Percentage of Participants With a Solicited Injection-site Adverse Event

    Time frame: Up to 14 days after any vaccination

    Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.

  5. Infants: Percentage of Participants With a Solicited Systemic Adverse Event

    Time frame: Up to 14 days after any vaccination

    Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.

  6. Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies

    Time frame: 1 month after Vaccination 3 (Month 5)

    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

Secondary outcomes

  1. Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies

    Time frame: 1 month after vaccination

    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  2. Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies

    Time frame: Baseline and 1 month after vaccination

    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.

  3. Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3

    Time frame: 1 month after Vaccination 3 (Month 5)

    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  4. Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4

    Time frame: Before Vaccination 4 (Month 10-13)

    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  5. Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4

    Time frame: 1 month after Vaccination 4 (Month 11-15)

    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  6. Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies

    Time frame: Before Vaccination 4 (Month 10-13)

    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  7. Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies

    Time frame: 1 month after Vaccination 4 (Month 11-15)

    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2015
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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