Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 6:01 AM
Study NCT ID:
NCT07348692
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000617220', 'term': 'Vaxelis'}, {'id': 'D022243', 'term': 'Rotavirus Vaccines'}, {'id': 'C492457', 'term': 'RIX4414 vaccine'}, {'id': 'C492535', 'term': 'RotaTeq'}, {'id': 'D022542', 'term': 'Measles-Mumps-Rubella Vaccine'}, {'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022362', 'term': 'Hepatitis A Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D008458', 'term': 'Measles Vaccine'}, {'id': 'D009108', 'term': 'Mumps Vaccine'}, {'id': 'D012411', 'term': 'Rubella Vaccine'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Participants, participant's parent(s) / LAR(s), Sponsor study staff, investigators and study staff, will remain blinded during the study conduct, except dedicated study staff preparing/administering the study interventions who will be blinded regarding the PCV21 lot but unblinded regarding the patients randomized in the 20vPCV arm. The unblinded study staff will not be involved in any safety evaluation."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 896}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-01-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)', 'timeFrame': '30 days after the third dose of PCV21 vaccine', 'description': 'Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL)'}], 'secondaryOutcomes': [{'measure': 'Serotype specific IgG concentration ≥ 0.35 µg/mL', 'timeFrame': '30 days after the third dose of PCV21 vaccine', 'description': 'Serotype specific IgG concentration ≥ 0.35 μg/mL (seroresponse) for all serotypes included in PCV21 as measured by ECL'}, {'measure': 'Presence of any immediate adverse events (AEs)', 'timeFrame': 'Within 30 minutes after each vaccine injection', 'description': 'Number of participants experiencing immediate AEs'}, {'measure': 'Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection', 'timeFrame': 'Through 7 days after each vaccine injection', 'description': 'Number of participants experiencing solicited injection site and systemic reactions'}, {'measure': 'Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs', 'timeFrame': 'Through 30 days after each vaccine injection', 'description': 'Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs'}, {'measure': 'Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study', 'timeFrame': 'Throughout the study (through 6 months post-last vaccine injection)', 'description': 'Number of participants experiencing SAEs and AESIs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumococcal Infection', '21 Valent Pneumococcal Vaccine'], 'conditions': ['Pneumococcal Immunization', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a phase 3 randomized, modified double-blind study which purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given in infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).\n\nThe study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV vaccines) will be administered at approximately 2, 4, 6 and 12 months of age. Routine pediatric vaccines will be given as per local recommendations.\n\nThere will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '89 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 42 to 89 days on the day of inclusion\n* Participants who are healthy as determined by medical evaluation including medical history and physical examination\n* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable\n\nExclusion Criteria:\n\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy\n* History of microbiologically confirmed Streptococcus pneumoniae infection or disease\n* Any contraindication to the routine pediatric vaccine being administered in the study\n* History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy\n* Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3\n* Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n* Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \\[≥ 100.4°F\\]) on the day of study intervention administration.\n* Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period\n* Previous vaccination against Streptococcus pneumoniae\n* Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus\n* Receipt of more than 1 dose of hepatitis B vaccine\n* Receipt of immune globulins, blood or blood-derived products since birth\n* Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure\n\nNote: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT07348692', 'briefTitle': 'Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, Lot-to-lot Consistency, 4-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers', 'orgStudyIdInfo': {'id': 'PSK00029'}, 'secondaryIdInfos': [{'id': 'PSK00029', 'type': 'OTHER', 'domain': 'Sanofi Identifier'}, {'id': 'U1111-1308-6832', 'type': 'OTHER', 'domain': 'WHO ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: PCV21', 'description': 'Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.', 'interventionNames': ['Biological: PCV21 vaccine', 'Biological: Vaxelis Vaccine', 'Biological: Rotavirus vaccine', 'Biological: Measles Mumps and Rubella Vaccine', 'Biological: Varivax vaccine', 'Biological: Hepatitis A Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: PCV21', 'description': 'Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.', 'interventionNames': ['Biological: PCV21 vaccine', 'Biological: Vaxelis Vaccine', 'Biological: Rotavirus vaccine', 'Biological: Measles Mumps and Rubella Vaccine', 'Biological: Varivax vaccine', 'Biological: Hepatitis A Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: PCV21', 'description': 'Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.', 'interventionNames': ['Biological: PCV21 vaccine', 'Biological: Vaxelis Vaccine', 'Biological: Rotavirus vaccine', 'Biological: Measles Mumps and Rubella Vaccine', 'Biological: Varivax vaccine', 'Biological: Hepatitis A Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4: 20vPCV', 'description': 'Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.', 'interventionNames': ['Biological: 20vPCV licensed vaccine', 'Biological: Vaxelis Vaccine', 'Biological: Rotavirus vaccine', 'Biological: Measles Mumps and Rubella Vaccine', 'Biological: Varivax vaccine', 'Biological: Hepatitis A Vaccine']}], 'interventions': [{'name': 'PCV21 vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['515'], 'description': 'Pharmaceutical form: Suspension for injection\n\nRoute of administration: Intramuscular', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: PCV21', 'Group 3: PCV21']}, {'name': '20vPCV licensed vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Prevnar 20™'], 'description': 'Pharmaceutical form: Suspension for injection\n\nRoute of administration: Intramuscular', 'armGroupLabels': ['Group 4: 20vPCV']}, {'name': 'Vaxelis Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Vaxelis™'], 'description': 'Pharmaceutical form: Suspension for injection\n\nRoute of administration: Intramuscular', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: PCV21', 'Group 3: PCV21', 'Group 4: 20vPCV']}, {'name': 'Rotavirus vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Rotarix™ or RotaTeq™'], 'description': 'Pharmaceutical form: Solution or Suspension for oral use\n\nRoute of administration: Oral', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: PCV21', 'Group 3: PCV21', 'Group 4: 20vPCV']}, {'name': 'Measles Mumps and Rubella Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['M-M-R II™ or Priorix™'], 'description': 'Pharmaceutical form: Liquid solution\n\nRoute of administration: Oral', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: PCV21', 'Group 3: PCV21', 'Group 4: 20vPCV']}, {'name': 'Varivax vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['VARIVAX™'], 'description': 'Pharmaceutical form: Powder, lyophilized, for suspension for reconstitution\n\nRoute of administration: Subcutaneous or IM', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: PCV21', 'Group 3: PCV21', 'Group 4: 20vPCV']}, {'name': 'Hepatitis A Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['VAQTA™ or Havrix™'], 'description': 'Pharmaceutical form: single-dose vial or single dose prefilled syringe or suspension for injection\n\nRoute of Administration: IM', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: PCV21', 'Group 3: PCV21', 'Group 4: 20vPCV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21104', 'city': 'San Pedro Sula', 'status': 'RECRUITING', 'country': 'Honduras', 'facility': 'Investigational Site Number : 3400001', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}, {'zip': '11101', 'city': 'Tegucigalpa', 'status': 'RECRUITING', 'country': 'Honduras', 'facility': 'Investigational Site Number : 3400002', 'geoPoint': {'lat': 14.0818, 'lon': -87.20681}}, {'zip': '11101', 'city': 'Tegucigalpa', 'status': 'RECRUITING', 'country': 'Honduras', 'facility': 'Investigational Site Number : 3400003', 'geoPoint': {'lat': 14.0818, 'lon': -87.20681}}], 'centralContacts': [{'name': 'Trial Transparency email recommended (Toll free for US & Canada)', 'role': 'CONTACT', 'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'phoneExt': 'option 6'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}