| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03620162 | A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION) | PHASE3 | COMPLETED | 900 | — | — | Oct 18, 2018 | Dec 14, 2020 | Jan 17, 2023 | 34 | United States, Puerto Rico +2 |
| NCT02225587 | Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029) | PHASE3 | COMPLETED | 400 | — | — | Aug 28, 2014 | Jul 6, 2015 | Nov 2, 2021 | - | — |
| NCT01215175 | Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001) | PHASE1 | COMPLETED | 150 | — | — | Sep 25, 2009 | Jan 5, 2011 | Mar 18, 2019 | - | — |
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.
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.
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.
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.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.
Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.
A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose.
A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13™ and PNEUMOVAX™ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
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.
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.
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
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. Relatedness of the AE to study vaccine was determined by the investigator.
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. Relatedness of the AE to study vaccine was determined by the investigator.
| Arm | Type | Description |
|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | ACTIVE_COMPARATOR | Participants will receive a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | EXPERIMENTAL | Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | EXPERIMENTAL | Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. |
| Group 4: Prevnar 13™-V114-V114-V114 | EXPERIMENTAL | Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. |
| Group 5: V114-V114-V114-V114 | EXPERIMENTAL | Participants will receive a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. |
| Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo | EXPERIMENTAL | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible. |
| Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 | PLACEBO_COMPARATOR | Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible. |
| Prevnar™ - Adult Cohort | ACTIVE_COMPARATOR | Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1. |
| V114 Adjuvanted -Toddler Cohort | EXPERIMENTAL | Healthy toddler (12-15 months of age) participants who had completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. |
| V114 Nonadjuvanted-Toddler Cohort | EXPERIMENTAL | Healthy toddlers (12-15 months of age) participants who completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of non-adjuvanted V114 on Day 1. |
| Prevnar™- Toddler Cohort | ACTIVE_COMPARATOR | Healthy toddlers (12-15 months of age) participants who had previously completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1. |
| V114 Adjuvanted -Adult Cohort | EXPERIMENTAL | Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. |
| Name | Type | Description |
|---|---|---|
| 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. |
| RotaTeq™ | BIOLOGICAL | RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution. |
| 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. |
| 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. |
| 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. |
| 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. |
| VARIVAX™ | BIOLOGICAL | VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration. |
| Pneumovax™ 23 | BIOLOGICAL | Pneumococcal vaccine containing serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Injections are to be administered into the deltoid muscle of the upper arm. |
| Placebo | BIOLOGICAL | Injections are to be administered into the deltoid muscle of the upper arm. |
| Prevnar™ | BIOLOGICAL | 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose. |
| V114, Aluminum Adjuvanted | BIOLOGICAL | 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose. |
| V114, Aluminum Nonadjuvanted | BIOLOGICAL | 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose. |
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...