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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002413-11 | EudraCT Number | ||
| PRI01C | Other Identifier | MCMVaccBV Protocol ID | |
| V419-011 | Other Identifier | Merck Protocol Number |
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The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V419 and MCC-TT | Experimental | Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of a measles, mumps, and rubella (MMR) vaccine (at 12 months of age). |
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| V419 and MCC-CRM | Experimental | Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V419 | Biological | Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate [meningococcal outer membrane protein complex], and Hepatitis B [recombinant] vaccine administered via 0.5 mL intramuscular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1) | The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. | Month 5 (1 month after MCC-TT/MCC-CRM Dose 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1) | The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >80%. Serum Ab levels were determined with radioimmunoassay (RIA). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Infant participants were enrolled at 11 study sites in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | V419 and MCC-TT | In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). |
| FG001 | V419 and MCC-CRM | In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Infant Vaccinations) |
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| Interim Period |
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| Period 2: Toddler Vaccinations |
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| ID | Title | Description |
|---|---|---|
| BG000 | V419 and MCC-TT | In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1) | The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 5 (1 month after MCC-TT/MCC-CRM Dose 2) |
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Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V419 and MCC-TT | In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000617220 | Vaxelis |
| C538862 | 13-valent pneumococcal vaccine |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| PREVNAR 13® | Biological | Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination). |
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| MCC-TT | Biological | Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age |
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| MCC-CRM | Biological | Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age |
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| Hib-MCC | Biological | Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection. |
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| MMR Vaccine | Biological | Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination). |
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| Month 5 (1 month after V419 Dose 3) |
| Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) | The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. | Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) |
| Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) | Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay. | Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) |
| Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1) | The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid [PT]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 [FIM]; and pertactin [PRN]) was determined as 1) if pre-vaccination Ab concentration \ | Month 5 (1 month after V419 Dose 3) |
| Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2) | The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA). | Month 5 (1 month after V419 Dose 3) |
| Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2) | The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay. | Month 5 (1 month after V419 Dose 3) |
| Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2) | The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT). | Month 5 (1 month after V419 Dose 3) |
| Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2) | The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA). | Month 5 (1 month after V419 Dose 3) |
| Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2) | The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA). | Month 5 (1 month after V419 Dose 3) |
| Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2) | The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay. | Month 5 (1 month after V419 Dose 3) |
| Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2) | The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay. | Month 5 (1 month after V419 Dose 3) |
| Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2) | The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay. | Month 5 (1 month after V419 Dose 3) |
| Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2) | The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT). | Month 5 (1 month after V419 Dose 3) |
| Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2) | The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. | Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC) |
| Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2) | Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. | Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC) |
| Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2) | The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA). | Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) |
| Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2) | Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL.. | Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) |
| Percentage of Participants Experiencing an Adverse Event (AE) [Part 1] | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
| Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1] | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related. | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
| Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) | The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
| Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) | The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited. | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
| Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) | The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
| Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) | The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth. | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
| Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1] | The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting. | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
| Percentage of Participants Experiencing Increased Temperature [Part 1] | The percentage of participants experiencing temperatures ≥38.0° Celsius (C), >38.5° C, and >39.5° C following any Part 1 vaccination was determined. | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
| Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1] | An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant. | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| NOT COMPLETED |
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| BG001 | V419 and MCC-CRM | In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). |
| BG002 | Total | Total of all reporting groups |
| Days |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | V419 and MCC-CRM | In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). |
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| Secondary | Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1) | The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >80%. Serum Ab levels were determined with radioimmunoassay (RIA). | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) | The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) |
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| Secondary | Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1) | Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay. | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | Titres | Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) |
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| Secondary | Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1) | The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid [PT]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 [FIM]; and pertactin [PRN]) was determined as 1) if pre-vaccination Ab concentration \ | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2) | The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA). | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2) | The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay. | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2) | The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT). | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2) | The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA). | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2) | The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA). | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2) | The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay. | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2) | The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay. | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2) | The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay. | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2) | The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT). | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | titre (1/dil) | Month 5 (1 month after V419 Dose 3) |
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| Secondary | Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2) | The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. | All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC) |
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| Secondary | Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2) | Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay. | All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included. | Posted | Geometric Mean | 95% Confidence Interval | tire (1/dil) | Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC) |
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| Secondary | Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2) | The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA). | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) |
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| Secondary | Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2) | Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL.. | All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2) |
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| Secondary | Percentage of Participants Experiencing an Adverse Event (AE) [Part 1] | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. | All randomized participants who received ≥1 dose of study medication in Part 1 are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| Secondary | Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1] | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related. | All randomized participants who received ≥1 dose of study medication in Part 1 are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| Secondary | Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) | The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. | All randomized participants who received ≥1 dose of study medication in Part 1 are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| Secondary | Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1) | The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited. | All randomized participants who received ≥1 dose of study medication in Part 1 are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| Secondary | Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) | The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling. | All randomized participants who received ≥1 dose of study medication in Part 1 are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| Secondary | Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1) | The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth. | All randomized participants who received ≥1 dose of study medication in Part 1 are included. | Posted | Number | Percentage of Participants | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| Secondary | Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1] | The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting. | All randomized participants who received ≥1 dose of study medication in Part 1 are included. | Posted | Number | Percentage of Participants | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| Secondary | Percentage of Participants Experiencing Increased Temperature [Part 1] | The percentage of participants experiencing temperatures ≥38.0° Celsius (C), >38.5° C, and >39.5° C following any Part 1 vaccination was determined. | All randomized participants who received ≥1 dose of study medication in Part 1 are included. | Posted | Number | Percentage of Participants | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| Secondary | Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1] | An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant. | All randomized participants who received ≥1 dose of study medication in Part 1 are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 4.5 months (up to 15 days after the final Part 1 vaccination) |
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| 0 |
| 142 |
| 6 |
| 142 |
| 140 |
| 142 |
| EG001 | V419 and MCC-CRM | In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age). | 0 | 142 | 4 | 142 | 137 | 142 |
| Crying | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypothermia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Croup infectious | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Gastroenteritis salmonella | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Sepsis neonatal | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Weight gain poor | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Crying | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site mass | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site warmth | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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Not provided
Not provided
| D008458 |
| Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
| Post-MCC Dose 1: % with ≥1:128 dil |
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| Post-MCC Dose 2: % with ≥1:8 dil |
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| Post-MCC Dose 2: % with ≥1:128 dil |
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| Anti-HBsAG ≥10 mIU/mL |
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| Anti-Diptheria ≥0.01 IU/mL |
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| Anti-Diptheria ≥0.1 IU/mL |
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| Anti-Tetanus ≥0.01 IU/mL |
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| Anti-Tetanus ≥0.1 IU/mL |
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| Anti-PT seroresponse |
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| Anti-FHA seroresponse |
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| Anti-PRN seroresponse |
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| Anti-FIM seroresponse |
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| Anti-Polio 1 ≥ 1:8 dil |
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| Anti-Polio 2 ≥ 1:8 dil |
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| Anti-Polio 3 ≥ 1:8 dil |
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| Anti-Polio 2 GMT |
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| Anti-Polio 3 GMT |
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| Pre-Hib anti-MCC: % with titre ≥1:28 (1/dil) |
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| Post-Hib anti-MCC: % with titre ≥1:8 (1/dil) |
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| Post-Hib anti-MCC: % with titre ≥1:28 (1/dil) |
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| Post-Hib anti-MCC GMT |
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| Pre-Hib-MCC anti-PRP ≥1.0 µg/mL |
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| Post-Hib-MCC anti-PRP ≥0.15 µg/mL |
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| Post-Hib-MCC anti-PRP ≥1.0 µg/mL |
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| Pre-Hib-MCC anti-PRP ≥1.0 µg/mL |
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| Swelling |
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| Swelling |
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| Erythema |
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| Induration |
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| Mass |
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| Pain |
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| Rash |
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| Warmth |
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| Irritability |
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| Pyrexia |
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| Somnolence |
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| Vomiting |
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| % >39.5° C |
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