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Completed

NCT Number: NCT03620162

A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

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Key information

Conditions

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

Age range

42 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cooperativa de Facultad Medica Sanacoop ( Site 0057), Bayamón, Puerto Rico

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is Healthy, based on clinical judgment of the investigator
  • Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion criteria

  • Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
  • Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine
  • Has any contraindication to the concomitant study vaccines being administered in the study
  • Has a known or suspected impairment of immunological function
  • Has a history of congenital or acquired immunodeficiency
  • Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
  • Has or his/her mother has a documented hepatitis B surface antigen - positive test
  • Has known or history of functional or anatomic asplenia
  • Has failure to thrive based on the clinical judgment of the investigator
  • Has a known coagulation disorder contraindicating intramuscular vaccination
  • Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
  • Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
  • Has received a dose of any pneumococcal vaccine prior to study entry
  • Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
  • Has received a dose of rotavirus vaccine prior to study entry
  • Has received a blood transfusion or blood products, including immunoglobulins
  • Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study
  • Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
  • Has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.

Treatment and study plan

Prevnar 13™

Biological

Prevnar 13™ contains the 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 given via IM injection.

V114

Biological

V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.

Other names: VAXNEUVANCE™

RotaTeq™

Biological

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

Other names: V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

PENTACEL™

Biological

Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

RECOMBIVAX HB™

Biological

RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

Other names: V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Hiberix™

Biological

HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

M-M-R™ II

Biological

M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.

Other names: V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

VARIVAX™

Biological

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.

Other names: V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Primary outcomes

  1. Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

    Time frame: Up to ~14 days after each vaccination

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to ~14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling.

  2. Percentage of Participants With a Solicited Systemic AE

    Time frame: Up to ~14 days after each vaccination

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited systemic AEs was assessed for up to ~14 days after each vaccination. The solicited systemic AEs assessed were appetite lost/decreased appetite, irritability, drowsiness/somnolence and hives or welts/urticaria.

  3. Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)

    Time frame: Up to ~6 months after Vaccination 4 (up to ~19 months)

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgement. Relatedness of an SAE to the study vaccine was determined by the investigator. Per protocol, the percentage of participants with vaccine-related SAEs was assessed through 6 months following Vaccination 4.

  4. Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4

    Time frame: 30 Days after Vaccination 4 (Months 11-14)

    The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a pneumococcal electrochemiluminescence (PnECL) assay. Per protocol, 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified primary outcome analysis; 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified secondary outcome analysis and reported later in the record.

Secondary outcomes

  1. Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3

    Time frame: 30 Days after Vaccination 3 (Month 5)

    The concentration of anti-HBsAg was assessed using an enhanced chemiluminescence assay. The protocol-specified analysis of the percentage of participants with anti-HBsAg ≥10 mIU/mL at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, participants with anti-HBsAg ≥10 mIU/mL in Group 5 were compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Analysis of participants with anti-HBsAg ≥10 mIU/mL was not planned to be reported in Group 3 and Group 4, per protocol.

  2. Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3

    Time frame: 30 Days after Vaccination 3 (Month 5)

    The GMT of anti-rotavirus IgA was assessed using a serum IgA enzyme linked immunosorbent assay. The protocol specified analysis of anti-rotavirus IgA GMT at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, GMT of anti-rotavirus IgA in Group 5 was compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Anti-rotavirus IgA GMT analysis was not planned to be reported in Group 3 and Group 4, per protocol.

  3. GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3

    Time frame: 30 Days after Vaccination 3 (Month 5)

    The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ [1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] and 2 unique serotypes [22F, 33F]) was assessed using a PnECL assay. Per protocol, GMC of 15 IgG serotypes was assessed at 30 days post Vaccination 3.

  4. Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3

    Time frame: 30 Days after Vaccination 3 (Month 5)

    The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ [1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] and 2 unique serotypes [22F, 33F]) was assessed using a PnECL assay. Per protocol, percentage of participants with anti-PnP IgG concentrations ≥0.35 µg/mL was assessed at 30 days post Vaccination 3.

  5. Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4

    Time frame: 30 Days after Vaccination 4 (Months 11-14)

    The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a PnECL assay. Per protocol, GMC of 13 IgG serotypes was analysed by vaccine dosing schedules (Groups 1, 5). Per protocol, 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified secondary outcome analysis; 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified primary outcome analysis and reported earlier in the record.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2018
Registry last updated
Jan 17, 2023

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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